| Primary | Change in Colonic Transit Time From Baseline to Day 15 | Assessed using abdominal x-ray. Subjects will take 24 radiopaque markers for 6 consecutive days (144 radiopaque markers in total) immediately preceding the x-ray dates. | The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit). | Posted | | Mean | Standard Deviation | Hours | | Baseline and Day 15 | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 | Litesse Powder Containing 4 g Polydextrose | 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin | | OG003 | Placebo | Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin |
| | Units | Counts |
|---|
| Participants | - OG00045
- OG00143
- OG00243
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-1.7± 23.6
- OG0014.0± 23.4
- OG0022.5± 23.7
- OG003
|
|
| |
| Secondary | Change in Participant Assessment of Constipation Symptoms (PAC-SYM) From Baseline to Day 15 | Assessed using the PAC-SYM questionnaire (overall score, abdominal symptoms score, rectal symptoms score, and stool symptoms score). The PAC-SYM was developed as a brief, easily administered tool to assess symptom frequency and severity of chronic constipation. The authors used a definition for constipation was based on the Rome II criteria. This 12-item self-report measure is divided into the 3 symptom subscales of: abdominal, rectal and stool subscales. All items (sub-scores and the total score) are scored on a five-point Likert scale ranging from 0 (absence of symptom) to 4 (very severe) where lower scores are better. Scores for the total number of non-missing items within the subscale or total score are summed and divided by the total number of non-missing items for that subscale or total score. | The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit). | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline and Day 15 | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose |
|
| Secondary | Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15 | Assessed using the PAC-QoL questionnaire (Overall Score, Worries and Concerns Score, Physical Discomfort Score, Psychosocial Discomfort Score, and Satisfaction Score) The Patient Assessment of Constipation (PAC) was developed to address the need for a disease-specific patient-reported outcomes measure. It includes components from complementary symptom and quality of life questionnaires. The PAC-QOL contains 28 items grouped into 4 subscales covering: worries and concerns (11 items), physical discomfort (4 items), psychosocial discomfort (8 items), and satisfaction (5 items). A 5-point Likert response scale, ranging from 0 (not at all / none of the time) to 4 (extremely / all of the time), where lower scores are better. Scores are computed as the average non-missing item response within the subscale where each score is given equal weight; the global score is calculated as the mean of the 28-items. | The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit). | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline and Day 15 | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose |
|
| Secondary | Change in Bowel Function Index From Baseline to Day 15 | Assessed using the Bowel Function Index questionnaire (total score, ease of defecation, feeling of incomplete bowel evacuation, and personal judgement of constipation). Each of the three questions used a numerical analog scale (0 = easy/no difficulty/not at all, 100 = very strong/very difficult) for grading purposes. The three questions were calculated as single scores as well as by a total score defined as the average of the three questions. | The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit). | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline and Day 15 | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | |
|
| Secondary | Change in Adequate Relief of Constipation Symptoms From Baseline to Day 15 | Assessed using single question dichotomous tool. Adequate relief quantified the difference in the number of participants experiencing relief from constipation between participants supplemented with Litesse and those supplemented with a placebo at baseline and day 14. The units of analysis for the relief questionnaire were the number of participants who reported relief from constipation. | The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit). | Posted | | Count of Participants | | Participants | | Baseline and Day 15 | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 |
|
| Secondary | Change in Stool Frequency From Baseline to Day 15 | Participants will record the number of defecations per day in a daily diary | The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit). | Posted | | Mean | Standard Deviation | Number of Bowel Movements Per Day | | 14 day run-in and Week 2 of the 14-day supplementation period | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 | Litesse Powder Containing 4 g Polydextrose | 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin |
|
| Secondary | Change in Stool Consistency From Baseline to Day 15 | Stool consistency will be rated each day in a diary by using the Bristol Stool Scale Form. Bristol Stool Scale: The BSS is a categorical scale ranging from 1 to 7 that interprets the consistency of a single bowel movement; a single score is recorded and used for analysis. Lower scores are associated with hard and lumpy consistencies while higher scores are associated with soft or liquid consistencies. Generally, an optimal BSS scores ranges from 3 to 5. | The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit). | Posted | | Mean | Standard Deviation | scores on a scale | | 14 day run-in and Week 2 of the 14-day supplementation period | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin |
|
| Secondary | Change in the Degree of Straining During Defecation From Baseline to Day 15 | Degree of straining for each bowel movement will be recorded in a daily diary using a 5-point scale. The degree of straining is a rating scale ranging from 1 (not at al) to 5 (an extreme amount) that interprets the degree to which an individual must strain during a unique defecation; a single core is recorded and used for analysis. Scores were calculated as the weekly average of the daily degree of straining (1-5) where a lower score represented less straining. | The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit). | Posted | | Mean | Standard Deviation | scores on a scale | | 14 day run-in and Week 2 of the 14-day supplementation period | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin |
|
| Secondary | Change in the Sensation of Complete Bowel Emptying From Baseline to Day 15 | Sensation of complete bowel emptying for each bowel movement will be recorded in a daily diary on a dichotomous "yes" or "no" scale. The change in the sensation was defined as the change from baseline to week 2 in the percentage of complete bowel movements (CBMs) between participants supplemented with Litesse and those supplemented with a placebo. It assessed whether the participant felt as though their bowel movement was complete. The units of analysis for the sensation of complete bowel emptying was the weekly percentage of complete bowel movements, for each participant at run-in (week -1), week 1 and week 2. | The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit). | Posted | | Mean | Standard Deviation | Percentage of CBMs per week | | 14 day run-in and Week 2 of the 14-day supplementation period | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin |
|
| Secondary | Change in the Severity of Abdominal Discomfort From Baseline to Day 15 | Severity of abdominal discomfort will be recorded each day in a daily diary on a 5-point scale. The severity of abdominal discomfort was calculated from a rating scale ranging from 1 (not at all) to 5 very severe); a single score was recorded and used for analysis. Scores were calculated as the weekly average of the daily degree of discomfort where a lower score represented less straining. | The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit). | Posted | | Mean | Standard Deviation | scores on a scale | | 14 day run-in and Week 2 of the 14-day supplementation period | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | |
|
| Secondary | Change in the Bloating Severity From Baseline to Day 15 | Severity of bloating will be recorded each day in a daily diary on a 5-point scale. The severity of abdominal bloating was calculated from a rating scale ranging from 1 (not at all) to 5 very severe); a single score was recorded and used for analysis. Scores were calculated as the weekly average of the daily degree of bloating where a lower score represented less straining. | The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit). | Posted | | Mean | Standard Deviation | scores on a scale | | 14 day run-in and Week 2 of the 14-day supplementation period | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 |
|
| Secondary | Overall Product Satisfaction | Participants will be asked to rate their overall satisfaction with the study product's ability to relieve their constipation symptoms on a 5-point ordinal scale. The overall product satisfaction questionnaire consists of a single question that provides insight regarding the participants satisfaction on the product's ability to relieve constipation symptoms. The score that the participant indicates is considered the total score and no sub-scores are calculated. It is a rating scale that ranges from 1 (not at all satisfied) to 5 (very satisfied) where a higher score at the end-of-study indicates an improvement. | The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit). | Posted | | Mean | Standard Deviation | scores on a scale | | Assessed at Day 15 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin |
|
| Other Pre-specified | Change in Hemoglobin Levels From Baseline to Day 15 | Safety will be evaluated by measuring whole blood hematology (specifically hemoglobin in this outcome). | Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose). | Posted | | Mean | Standard Deviation | g/dL | | Screening and Day 15 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 | Litesse Powder Containing 4 g Polydextrose | 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin |
|
| Other Pre-specified | Change in Hematocrit Levels From Screening to Day 15 | Safety will be evaluated by measuring the change in whole blood hematology (specifically hematocrit levels in this outcome). | Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose). | Posted | | Mean | Standard Deviation | Percentage of red blood cells | | Screening and Day 15 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 | Litesse Powder Containing 4 g Polydextrose | 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin |
|
| Other Pre-specified | Change in White Blood Cell Count From Baseline to Day 15 | Safety will be evaluated by measuring whole blood hematology (specifically white blood cell count in this outcome measure). | Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose). | Posted | | Mean | Standard Deviation | 10^9 cells/L | | Screening and Day 15 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 | Litesse Powder Containing 4 g Polydextrose | 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin |
|
| Other Pre-specified | Change in Red Blood Cell Count From Baseline to Day 15 | Safety will be evaluated by measuring whole blood hematology (specifically red blood cell count in this outcome measure). | Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose). | Posted | | Mean | Standard Deviation | 10^12 cells/L | | Screening and Day 15 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 | Litesse Powder Containing 4 g Polydextrose | 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin |
|
| Other Pre-specified | Change in Mean Corpuscular Volume From Baseline to Day 15 | Safety will be evaluated by measuring whole blood hematology (specifically mean corpuscular volume in this outcome measure). | Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose). | Posted | | Mean | Standard Deviation | fL | | Screening and Day 15 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 | Litesse Powder Containing 4 g Polydextrose | 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin |
|
| Other Pre-specified | Change in Mean Corpuscular Hemoglobin From Baseline to Day 15 | Safety will be evaluated by measuring whole blood hematology (specifically mean corpuscular hemoglobin in this outcome measure). | Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose). | Posted | | Mean | Standard Deviation | pg | | Screening and Day 15 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 | Litesse Powder Containing 4 g Polydextrose | 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin |
|
| Other Pre-specified | Change in Mean Corpuscular Hemoglobin Concentration From Baseline to Day 15 | Safety will be evaluated by measuring whole blood hematology (specifically mean corpuscular hemoglobin concentration in this outcome measure). | Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose). | Posted | | Mean | Standard Deviation | g/dL | | Screening and Day 15 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 | Litesse Powder Containing 4 g Polydextrose | 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin |
|
| Other Pre-specified | Change in Red Cell Distribution Width From Baseline to Day 15 | Safety will be evaluated by measuring whole blood hematology (specifically red cell distribution width in this outcome measure). | Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose). | Posted | | Mean | Standard Deviation | percent of mean red blood cell volume | | Screening and Day 15 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 | Litesse Powder Containing 4 g Polydextrose | 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin |
|
| Other Pre-specified | Change in Platelet Count From Baseline to Day 15 | Safety will be evaluated by measuring whole blood hematology (specifically platelet count in this outcome measure). | Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose). | Posted | | Mean | Standard Deviation | 10^9 cells/L | | Screening and Day 15 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 | Litesse Powder Containing 4 g Polydextrose | 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin |
|
| Other Pre-specified | Change in Neutrophil Count From Baseline to Day 15 | Safety will be evaluated by measuring whole blood hematology (specifically neutrophil count in this outcome measure). | Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose). | Posted | | Mean | Standard Deviation | 10^9 cells/L | | Screening and Day 15 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 | Litesse Powder Containing 4 g Polydextrose | 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin |
|
| Other Pre-specified | Change in Lymphocyte Count From Baseline to Day 15 | Safety will be evaluated by measuring whole blood hematology (specifically lymphocyte count in this outcome measure). | Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose). | Posted | | Mean | Standard Deviation | 10^9 cells/L | | Screening and Day 15 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 | Litesse Powder Containing 4 g Polydextrose | 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin |
|
| Other Pre-specified | Change in Monocyte Count From Baseline to Day 15 | Safety will be evaluated by measuring whole blood hematology (specifically monocyte count in this outcome measure). | Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose). | Posted | | Mean | Standard Deviation | 10^9 cells/L | | Screening and Day 15 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 | Litesse Powder Containing 4 g Polydextrose | 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin |
|
| Other Pre-specified | Change in Eosinophil Count From Baseline to Day 15 | Safety will be evaluated by measuring whole blood hematology (specifically eosinophil count in this outcome measure). | Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose). | Posted | | Mean | Standard Deviation | 10^9 cells/L | | Screening and Day 15 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 | Litesse Powder Containing 4 g Polydextrose | 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin |
|
| Other Pre-specified | Change in Basophil Count From Baseline to Day 15 | Safety will be evaluated by measuring whole blood hematology (specifically basophil count in this outcome measure). | Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose). | Posted | | Mean | Standard Deviation | 10^9 cells/L | | Screening and Day 15 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 | Litesse Powder Containing 4 g Polydextrose | 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin |
|
| Other Pre-specified | Change in Serum Glucose Concentration From Baseline to Day 15 | Safety will be evaluated by measuring blood serum variables (specifically glucose concentration in this outcome measure). | The number analyzed from the Litesse powder 4g arm is only 47 due to laboratory analysis error. | Posted | | Mean | Standard Deviation | mmol/L | | Screening and Day 15 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 | Litesse Powder Containing 4 g Polydextrose | 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin | | OG003 |
|
| Other Pre-specified | Change in Creatinine Levels in Blood From Baseline to Day 15 | Safety will be evaluated by measuring blood serum variables (specifically creatinine concentration in this outcome measure). | | Posted | | Mean | Standard Deviation | μmol | | Screening and Day 15 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 | Litesse Powder Containing 4 g Polydextrose | 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin | | OG003 | Placebo | Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin |
|
| Other Pre-specified | Change in Serum Urea Concentration From Baseline to Day 15 | Safety will be evaluated by measuring blood serum variables (specifically urea concentration in this outcome measure). | | Posted | | Mean | Standard Deviation | mmol/L | | Screening and Day 15 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 | Litesse Powder Containing 4 g Polydextrose | 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin | | OG003 | Placebo | Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin |
|
| Other Pre-specified | Change in Serum Estimated Globular Filtration Rate From Baseline to Day 15 | Safety will be evaluated by measuring blood serum variables (specifically estimated glomerular filtration rate in this outcome measure). | | Posted | | Mean | Standard Deviation | mL/min/1.73m^2 | | Screening and Day 15 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 | Litesse Powder Containing 4 g Polydextrose | 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin | | OG003 | Placebo | |
|
| Other Pre-specified | Change in Serum Sodium Concentration From Baseline to Day 15 | Safety will be evaluated by measuring blood serum variables (specifically sodium concentration in this outcome measure). | | Posted | | Mean | Standard Deviation | mmol/L | | Screening and Day 15 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 | Litesse Powder Containing 4 g Polydextrose | 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin | | OG003 | Placebo | Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin |
|
| Other Pre-specified | Change in Serum Potassium Concentration From Baseline to Day 15 | Safety will be evaluated by measuring blood serum variables (specifically potassium concentration in this outcome measure). | One participant in the Litesse powder containing 4 g polydextrose arm did not have this blood serum variable analysed due to laboratory analysis error. | Posted | | Mean | Standard Deviation | mmol/L | | Screening and Day 15 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 | Litesse Powder Containing 4 g Polydextrose | 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin | |
|
| Other Pre-specified | Change in Serum Chloride Concentration From Baseline to Day 15 | Safety will be evaluated by measuring blood serum variables (specifically chloride concentration in this outcome measure). | | Posted | | Mean | Standard Deviation | mmol/L | | Screening and Day 15 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 | Litesse Powder Containing 4 g Polydextrose | 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin | | OG003 | Placebo | Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin |
|
| Other Pre-specified | Change in Serum Calcium Concentration From Baseline to Day 15 | Safety will be evaluated by measuring blood serum variables (specifically calcium concentration in this outcome measure). | | Posted | | Mean | Standard Deviation | mmol/L | | Screening and Day 15 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 | Litesse Powder Containing 4 g Polydextrose | 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin | | OG003 | Placebo | Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin |
|
| Other Pre-specified | Change in Serum Carbon Dioxide Concentration From Baseline to Day 15 | Safety will be evaluated by measuring blood serum variables (specifically carbon dioxide concentration in this outcome measure). | One participant in the Litesse powder containing 4 g polydextrose arm did not have this blood serum variable analysed due to laboratory analysis error. | Posted | | Mean | Standard Deviation | mmol/L | | Screening and Day 15 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 | Litesse Powder Containing 4 g Polydextrose | 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin | |
|
| Other Pre-specified | Change in Serum Phosphate Concentration From Baseline to Day 15 | Safety will be evaluated by measuring blood serum variables (specifically phosphate concentration in this outcome measure). | | Posted | | Mean | Standard Deviation | mmol/L | | Screening and Day 15 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 | Litesse Powder Containing 4 g Polydextrose | 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin | | OG003 | Placebo | Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin |
|
| Other Pre-specified | Change in Serum Bilirubin Concentration From Baseline to Day 15 | Safety will be evaluated by measuring blood serum variables (specifically bilirubin concentration in this outcome measure). | | Posted | | Mean | Standard Deviation | μmol/L | | Screening and Day 15 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 | Litesse Powder Containing 4 g Polydextrose | 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin | | OG003 | Placebo | Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin |
|
| Other Pre-specified | Change in Serum Aspartate Transaminase Concentration From Baseline to Day 15 | Safety will be evaluated by measuring blood serum variables (specifically aspartate transaminase concentration in this outcome measure). | | Posted | | Mean | Standard Deviation | U/L | | Screening and Day 15 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 | Litesse Powder Containing 4 g Polydextrose | 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin | | OG003 | Placebo | |
|
| Other Pre-specified | Change in Serum Alanine Transaminase Concentration From Baseline to Day 15 | Safety will be evaluated by measuring blood serum variables (specifically alanine transaminase concentration in this outcome measure). | | Posted | | Mean | Standard Deviation | U/L | | Screening and Day 15 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 | Litesse Powder Containing 4 g Polydextrose | 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin | | OG003 | Placebo | |
|
| Other Pre-specified | Change in Serum Alkaline Phosphate Concentration From Baseline to Day 15 | Safety will be evaluated by measuring blood serum variables (specifically alkaline phosphate concentration in this outcome measure). | | Posted | | Mean | Standard Deviation | U/L | | Screening and Day 15 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 | Litesse Powder Containing 4 g Polydextrose | 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin | | OG003 | Placebo | Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin |
|
| Other Pre-specified | Change in Serum Gamma-Glutamyltransferase Concentration From Baseline to Day 15 | Safety will be evaluated by measuring blood serum variables (specifically gamma-glutamyltransferase concentration in this outcome measure). | | Posted | | Mean | Standard Deviation | U/L | | Screening and Day 15 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 | Litesse Powder Containing 4 g Polydextrose | 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin | | OG003 | Placebo | |
|
| Other Pre-specified | Change in Serum C-Reactive Protein Concentration From Baseline to Day 15 | Safety will be evaluated by measuring blood serum variables (specifically C-reactive protein concentration in this outcome measure). | | Posted | | Mean | Standard Deviation | mg/L | | Screening and Day 15 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 | Litesse Powder Containing 4 g Polydextrose | 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin | | OG003 | Placebo | Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin |
|
| Other Pre-specified | Change in Specific Gravity Urinalysis Parameter From Screening to Day 15 | Safety will be evaluated by measuring urine analyses (specifically specific gravity in this outcome measure). The reference range for specific gravity are 1.001 - 1.030 mmol/L, with no alerting or critical values. | One participant from the 12 g polydextrose arm, one participant from the 8 g polydextrose arm, and three participants from the 4 g polydextrose arm were unable to have urinalysis parameters analysed. | Posted | | Mean | Standard Deviation | mmol/L | | Screening and Day 15 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 | Litesse Powder Containing 4 g Polydextrose | 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin |
|
| Other Pre-specified | Change in pH Urinalysis Parameter From Baseline to Day 15 | Safety will be evaluated by measuring urine analyses (specifically urine pH in this outcome measure). Urine pH reference range is between 5.0 - 8.0, with no alerting or critical values. | One participant from the 12 g polydextrose arm, one participant from the 8 g polydextrose arm, and three participants from the 4 g polydextrose arm were unable to have urinalysis parameters analysed. | Posted | | Mean | Standard Deviation | pH | | Screening and Day 15 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 | Litesse Powder Containing 4 g Polydextrose | 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin |
|
| Other Pre-specified | Number of Subjects With Adverse Events | Adverse events were recorded in a daily diary during the 14-day run-in period and the 14-day treatment period. All types of adverse events as well as the total number of all adverse events reported were used in this outcome measure. | The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit). | Posted | | Number | | Number of Adverse Events | | 14 days run-in and 14 days treatment | | | | ID | Title | Description |
|---|
| OG000 | Litesse Powder Containing 12 g Polydextrose | 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose | | OG001 | Litesse Powder Containing 8 g Polydextrose | 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | | OG002 | Litesse Powder Containing 4 g Polydextrose | |
|