Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1K99AG065419-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
Not provided
Not provided
Not provided
Not provided
This is a dose escalation trial in the elderly with obesity to determine the maximum tolerated dose of a novel dietary fiber from whole young soy pods (soy) delivered in foods.
The tolerability to 10 g, 20 g, and 30 g of soy will be tested. At each dose, eight subjects will incorporate the foods containing soy into their usual diet for one week. The tolerability to each dose will be evaluated and fecal short chain fatty acids will be measured as a biomarker of compliance. Subjects who satisfy the eligibility criteria and express willingness to consume the study foods will be enrolled.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Foods containing 10 g soy flour | Experimental | Participants will receive foods containing 10 g of soy flour to be consumed everyday for one week. If they tolerate the dose, they will receive the next dose without any wash-out period. |
|
| Foods containing 20 g soy flour | Experimental | Participants will receive foods containing 20 g of soy flour to be consumed everyday for one week. If they tolerate the dose, they will receive the next dose without any wash-out period. |
|
| Foods containing 30 g soy flour | Experimental | Participants will receive foods containing 30 g of soy flour to be consumed everyday for one week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Food | Other | Soy-fiber containing food |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events Following Each Dose of Soy | Dose safety will be investigated by compiling by treatment (e.g. 10 g dose, 20 g dose, 30 g dose) a list of adverse events such as frequency of headaches, nausea, vomiting. The study physician in consultation with the coordinator will review and determine safety | One week at each dose |
| 10 g Soy-related Gastrointestinal Symptoms | Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe. | One week |
| 20 g Soy-related Gastrointestinal Symptoms | Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe. | One week |
| 30 g Soy-related Gastrointestinal Symptoms | Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe. | One week |
| 10 g Soy-related Stool Frequency | Subjects will complete the stool frequency questionnaire. Stool frequency will be rated from 0 to more than 9 over three consecutive days in each week | One week |
| 20 g Soy-related Stool Frequency | Subjects will complete the stool frequency questionnaire. Stool frequency will be rated from 0 to more than 9 over three consecutive days in each week | One week |
| 30 g Soy-related Stool Frequency |
| Measure | Description | Time Frame |
|---|---|---|
| 10 g Soy Intake Effect on Fecal Short Chain Fatty Acids | Measurement of fecal short chain fatty acids in response to intake of soy | One week |
| 20 g Soy Intake Effect on Fecal Short Chain Fatty Acids |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Candida Rebello, Ph.D. | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study enrolled 8 subjects. Each subject started at the 10g soy flour dose and crossed over to the 20 g soy flour dose after one week if they tolerated the 10 g soy flour dose, and subsequently to the 30g soy flour dose if they tolerated the 20g soy flour dose.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Foods Containing 10 g Soy Flour | Participants will receive foods containing 10 g of soy flour to be consumed everyday for one week. Food: Soy-fiber containing food |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Foods Containing 10 g Soy Flour |
|
| ||||||||||||||||||
| Foods Containing 20 g Soy Flour |
| |||||||||||||||||||
| Foods Containing 30g Soy Flour |
|
The participant dropped from the study was excluded from the analysis. The data relates to seven participants who were tested for tolerance to the three doses of soy flour
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Participants will receive foods containing 10g, 20g, and 30g of soy flour to be consumed everyday for one week at each dose. Food: Soy-fiber containing food |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | One subject dropped from the study at day 3 of week one and was not included in the analysis |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events Following Each Dose of Soy | Dose safety will be investigated by compiling by treatment (e.g. 10 g dose, 20 g dose, 30 g dose) a list of adverse events such as frequency of headaches, nausea, vomiting. The study physician in consultation with the coordinator will review and determine safety | One subject dropped from the study at Day 3 of week one and was not included in the analysis. | Posted | Count of Participants | Participants | One week at each dose |
|
One week at each dose
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Foods Containing 10g Soy Flour | Participants will receive foods containing 10 g of soy flour to be consumed everyday for one week. Food: Soy-fiber containing food |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| flatulence | Gastrointestinal disorders | Systematic Assessment | Mild flatulence |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Candida Rebello | Pennington Biomedical Research Center | 2252882411 | Candida.Rebello@pbrc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 4, 2022 | Mar 29, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 4, 2022 | Mar 29, 2023 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D005502 | Food |
| ID | Term |
|---|---|
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
Not provided
Not provided
Dose escalating cross over trial
Not provided
Not provided
Not provided
Not provided
Subjects will complete the stool frequency questionnaire. Stool frequency will be rated from 0 to more than 9 over three consecutive days in each week |
| One week |
| 10 Soy-related Stool Consistency | Subjects will complete a stool consistency questionnaire. Stool consistency will be rated according to the Bristol Stool Scale where scores from three to five will be considered normal and 1, 2, 6, and 7 will be considered abnormal. | One week |
| 20 g Soy-related Stool Consistency | Subjects will complete a stool consistency questionnaire. Stool consistency will be rated according to the Bristol Stool Scale where scores from three to five will be considered normal and 1, 2, 6, and 7 will be considered abnormal. | One week |
| 30 g Soy-related Stool Consistency | Subjects will complete a stool consistency questionnaire. Stool consistency will be rated according to the Bristol Stool Scale where scores from three to five will be considered normal and 1, 2, 6, and 7 will be considered abnormal. | One week |
Measurement of fecal short chain fatty acids in response to intake of soy
| One week |
| 30 g Soy Intake Effect on Fecal Short Chain Fatty Acids | Measurement of fecal short chain fatty acids in response to intake of soy | One week |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | One subject dropped from the study at Day 3 of week one and was not included in the analysis | Count of Participants | Participants |
|
| Race (NIH/OMB) | One subject dropped from the study at Day 3 of week one and was not included in the analysis. | Count of Participants | Participants |
|
| Region of Enrollment | Each of the seven subjects crossed over to the next treatment | Number | participants |
|
| Body Mass Index | Each of the seven subjects crossed over to the next treatment | Mean | Standard Deviation | kg/m^2 |
|
Participants will receive foods containing 20 g of soy flour to be consumed everyday for one week. Food: Soy-fiber containing food |
| OG002 | Foods Containing 30 g Soy Flour | Participants will receive foods containing 30 g of soy flour to be consumed everyday for one week. Food: Soy-fiber containing food |
|
|
| Primary | 10 g Soy-related Gastrointestinal Symptoms | Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe. | One subject dropped from the study at Day 3 of week one and was excluded from the analysis. | Posted | Count of Participants | Participants | One week |
|
|
|
| Primary | 20 g Soy-related Gastrointestinal Symptoms | Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe. | One subject dropped out of the study on Day 3 of Week 1 and was not included in the analysis. | Posted | Count of Participants | Participants | One week |
|
|
|
| Primary | 30 g Soy-related Gastrointestinal Symptoms | Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe. | One subject dropped out of the study on Day 3 of Week 1 and was not included in the analysis. | Posted | Count of Participants | Participants | One week |
|
|
|
| Primary | 10 g Soy-related Stool Frequency | Subjects will complete the stool frequency questionnaire. Stool frequency will be rated from 0 to more than 9 over three consecutive days in each week | One subject dropped out of the study on Day 3 of Week 1 and was not included in the analysis. | Posted | Count of Participants | Participants | One week |
|
|
|
| Primary | 20 g Soy-related Stool Frequency | Subjects will complete the stool frequency questionnaire. Stool frequency will be rated from 0 to more than 9 over three consecutive days in each week | Posted | Count of Participants | Participants | One week |
|
|
|
| Primary | 30 g Soy-related Stool Frequency | Subjects will complete the stool frequency questionnaire. Stool frequency will be rated from 0 to more than 9 over three consecutive days in each week | Posted | Count of Participants | Participants | One week |
|
|
|
| Primary | 10 Soy-related Stool Consistency | Subjects will complete a stool consistency questionnaire. Stool consistency will be rated according to the Bristol Stool Scale where scores from three to five will be considered normal and 1, 2, 6, and 7 will be considered abnormal. | Posted | Count of Participants | Participants | One week |
|
|
|
| Primary | 20 g Soy-related Stool Consistency | Subjects will complete a stool consistency questionnaire. Stool consistency will be rated according to the Bristol Stool Scale where scores from three to five will be considered normal and 1, 2, 6, and 7 will be considered abnormal. | One subject was dropped from the study on Day 3 of week 1 and was not included in the analysis | Posted | Count of Participants | Participants | One week |
|
|
|
| Primary | 30 g Soy-related Stool Consistency | Subjects will complete a stool consistency questionnaire. Stool consistency will be rated according to the Bristol Stool Scale where scores from three to five will be considered normal and 1, 2, 6, and 7 will be considered abnormal. | One subject was dropped from the study at Day 3 and was not included in the analysis | Posted | Count of Participants | Participants | One week |
|
|
|
| Secondary | 10 g Soy Intake Effect on Fecal Short Chain Fatty Acids | Measurement of fecal short chain fatty acids in response to intake of soy | One subject was dropped from the study at Day 3 and was excluded from the analysis | Posted | Mean | Standard Error | mg fecal short chain fatty acids/g dry f | One week |
|
|
|
| Secondary | 20 g Soy Intake Effect on Fecal Short Chain Fatty Acids | Measurement of fecal short chain fatty acids in response to intake of soy | One subject was dropped from the study at Day 3 and was excluded from the analysis. | Posted | Mean | Standard Error | mg fecal short chain fatty acids/g dry f | One week |
|
|
|
| Secondary | 30 g Soy Intake Effect on Fecal Short Chain Fatty Acids | Measurement of fecal short chain fatty acids in response to intake of soy | One subject was dropped from the study at Day 3 and was excluded from the analysis | Posted | Mean | Standard Error | mg fecal short chain fatty acids/g dry f | One week |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Foods Containing 20g Soy Flour | Participants will receive foods containing 20 g of soy flour to be consumed everyday for one week. Food: Soy-fiber containing food | 0 | 7 | 0 | 7 | 1 | 7 |
| EG002 | Foods Containing 30g Soy Flour | Participants will receive foods containing 30 g of soy flour to be consumed everyday for one week. Food: Soy-fiber containing food | 0 | 7 | 0 | 7 | 1 | 7 |
| Constipation | Gastrointestinal disorders | Systematic Assessment | Mild constipation |
|
Not provided
Not provided
| None |
|
| Flatulence |
|
| Abdominal Pain |
|
| None |
|
| Flatulence |
|
| Abdominal pain |
|
| None |
|
| Flatulence |
|
| Abdominal Pain |
|
| 1, Abnormal(Separate hard lumps) |
|
| 2, Abnormal (Sausage-shaped but lumpy) |
|
| 6, Abnormal (Fluffy pieces with ragged edges) |
|
| 7, Abnormal (Watery) |
|
| 1, Abnormal (Separate hard lumps) |
|
| 2, Abnormal (Sausage-shaped but lumpy) |
|
| 6, Abnormal (Fluffy pieces with ragged edges) |
|
| 7, Abnormal (Watery) |
|
| 1, Abnormal (Separate hard lumps) |
|
| 2, Abnormal (Sausage-shaped but lumpy) |
|
| 6, Abnormal (Fluffy pieces with ragged edges) |
|
| 7, Abnormal (Watery) |
|