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| Name | Class |
|---|---|
| INNOSUPPS | UNKNOWN |
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The purpose of the present study is to investigate the impact of a natural dietary supplement, Inno Cleanse™, to reduce bloating in a population of otherwise healthy men and women, who claim to feel frequently bloated. Inno CleanseTM dietary supplement is manufactured in the United States under current Good Manufacturing Practices (cGMP) and is marketed by InnoSupps as a digestive health aid. It is sold in the United States on the company's website, Amazon, and in many large retail outlets. It remains a very popular product, with close to 1.4 million units sold since 2020, with a reported 66,000 units sold in the past three months.
Despite the prevalence of dietary supplements identifying as digestive aids, detoxification, and cleanses, very little research has been done to determine their effectiveness. The product appears to be well-designed, with multiple ingredients included which have scientific evidence of effectiveness. That said, and despite the overall positive reviews, there is no known clinical research to support the product's effectiveness.
Therefore, the aim of this study is to evaluate the efficacy of the Inno Cleanse product to reduce bloating and result in other positive outcomes (weight loss). This study will be run as a double-blind placebo-controlled trial, in which subjects will use the product or placebo for two weeks. It is hypothesized that treatment with the dietary supplement Inno Cleanse will result in reduced bloating, as evidenced by self-reported reductions in bloating and hunger, as well as moderate weight loss and a reduction in body circumference measures due to the reduced bloating. In addition, multiple anecdotal reports of improved skin health have been noted in those using the product. Additionally, routine blood and urine sample analysis will be performed as a secondary outcome, as a safety measure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Dietary Supplement | Experimental | 15 randomly assigned individuals will receive 2 capsules daily of the experimental dietary supplement for 2 weeks with assessments prior and after intervention. |
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| Placebo Control | Placebo Comparator | 15 randomly assigned individuals will receive 2 capsules daily of the placebo for 2 weeks with assessments prior and after intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary supplement for digestive health | Dietary Supplement | Dietary supplement contains cascara sagrada bark powder, cape aloe leaves extract, senna leaf powder, frangula bark powder fennel seed powder, bentonite clay, burdock root powder, licorice root extract, slippery elm bark powder, Capiscum annuum L. Fruit powder, milk thistle seed powder, hydroxypropyl methylcellulose, and silicon dioxide. |
| Measure | Description | Time Frame |
|---|---|---|
| Alanine transaminase | Alanine transaminase measured as part of metabolic panel in international units per liter | baseline |
| Alanine transaminase | Alanine transaminase measured as part of metabolic panel in international units per liter | 2 weeks of assigned intervention |
| Aspartate transferase | Aspartate transferase measured as part of metabolic panel in international units per liter | baseline |
| Aspartate transferase | Aspartate transferase measured as part of metabolic panel in international units per liter | 2 weeks of assigned intervention |
| Albumin | Albumin measured as part of metabolic panel in grams per deciliter | baseline |
| Albumin | Albumin measured as part of metabolic panel in grams per deciliter | 2 weeks of assigned intervention |
| Alkaline phosphatase | Alkaline phosphatase measured as part of metabolic panel in international units per liter | baseline |
| Alkaline phosphatase | Alkaline phosphatase measured as part of metabolic panel in international units per liter |
| Measure | Description | Time Frame |
|---|---|---|
| Daily food diary | Daily food diary of all food and drink consumed that day | 3 days prior to baseline visit |
| Daily food diary | Daily food diary of all food and drink consumed that day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacquelyn Pence, PhD | Contact | 901-678-1547 | jpence1@memphis.edu |
| Name | Affiliation | Role |
|---|---|---|
| Richard Bloomer, PhD | University of Memphis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Nutraceutical and Dietary Supplement Research | Recruiting | Memphis | Tennessee | 38152 | United States |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| placebo capsule | Dietary Supplement | Contains hydroxypropyl methylcellulose and cellulose |
|
| 2 weeks of assigned intervention |
| Total bilirubin | Total bilirubin measured as part of metabolic panel in milligrams per deciliter | baseline |
| Total Bilirubin | Total bilirubin measured as part of metabolic panel in milligrams per deciliter | 2 weeks of assigned intervention |
| Blood urea nitrogen | Blood urea nitrogen measured as part of metabolic panel in milligrams per deciliter | baseline |
| Blood urea nitrogen | Blood urea nitrogen measured as part of metabolic panel in milligrams per deciliter | 2 weeks of assigned intervention |
| Calcium | Calcium measured as part of metabolic panel in milligrams per deciliter | baseline |
| Calcium | Calcium measured as part of metabolic panel in milligrams per deciliter | 2 weeks of assigned intervention |
| Carbon dioxide | Carbon dioxide measured as part of metabolic panel in millimoles per liter | baseline |
| Carbon dioxide | Carbon dioxide measured as part of metabolic panel in millimoles per liter | 2 weeks of assigned intervention |
| Chloride | Chloride measured as part of metabolic panel in millimoles per liter. | baseline |
| Chloride | Chloride measured as part of metabolic panel in millimoles per liter. | 2 weeks of assigned intervention |
| Creatinine | Creatinine measured as part of metabolic panel in milligrams per deciliter | baseline |
| Creatinine | Creatinine measured as part of metabolic panel in milligrams per deciliter | 2 weeks of assigned intervention |
| Estimated glomerular filtration rate | Estimated glomerular filtration rate as part of metabolic panel in milliliters per minute per 1.73 | baseline |
| Estimated glomerular filtration rate | Estimated glomerular filtration rate as part of metabolic panel in milliliters per minute per 1.73 | 2 weeks of assigned intervention |
| Blood Glucose | Glucose measured as part of metabolic panel in milligrams per deciliter | baseline |
| Blood Glucose | Glucose measured as part of metabolic panel in milligrams per deciliter | 2 weeks of assigned intervention |
| Potassium | Potassium measured as part of metabolic panel in millimoles per liter. | baseline |
| Potassium | Potassium measured as part of metabolic panel in millimoles per liter. | 2 weeks of assigned intervention |
| Sodium | Sodium measured as part of metabolic panel in millimoles per liter. | baseline |
| Sodium | Sodium measured as part of metabolic panel in millimoles per liter. | 2 weeks of assigned intervention |
| Total Globulin | Total Globulin measured as part of metabolic panel in grams per deciliter | baseline |
| Total Globulin | Total Globulin measured as part of metabolic panel in grams per deciliter | 2 weeks of assigned intervention |
| Total Protein | Total Protein measured as part of metabolic panel in grams per deciliter | baseline |
| Total Protein | Total Protein measured as part of metabolic panel in grams per deciliter | 2 weeks of assigned intervention |
| Albumin/globulin ratio | Albumin/globulin ratio measured as part of metabolic panel | baseline |
| Albumin/globulin ratio | Albumin/globulin ratio measured as part of metabolic panel | 2 weeks of assigned intervention |
| Blood urea nitrogen/creatinine ratio | Blood urea nitrogen/creatinine ratio measured as part of metabolic panel | baseline |
| Blood urea nitrogen/creatinine ratio | Blood urea nitrogen/creatinine ratio measured as part of metabolic panel | 2 weeks of assigned intervention |
| Hematocrit | Hematocrit as part of a complete blood count panel measured as percentage | baseline |
| Hematocrit | Hematocrit as part of a complete blood count panel measured as percentage | 2 weeks of assigned intervention |
| Hemoglobin | Hemoglobin as part of a complete blood count panel measured in grams per deciliter | baseline |
| Hemoglobin | Hemoglobin as part of a complete blood count panel measured in grams per deciliter | 2 weeks of assigned intervention |
| Mean corpuscular volume | Mean corpuscular volume as part of a complete blood count panel measured in femtoliters | baseline |
| Mean corpuscular volume | Mean corpuscular volume as part of a complete blood count panel measured in femtoliters | 2 weeks of assigned intervention |
| Mean corpuscular hemoglobin | Mean corpuscular hemoglobin as part of a complete blood count panel measured in picograms | baseline |
| Mean corpuscular hemoglobin | Mean corpuscular hemoglobin as part of a complete blood count panel measured in picograms | 2 weeks of assigned intervention |
| Mean corpuscular hemoglobin concentration | Mean corpuscular hemoglobin concentration as part of a complete blood count panel measured in grams per deciliter | baseline |
| Mean corpuscular hemoglobin concentration | Mean corpuscular hemoglobin concentration as part of a complete blood count panel measured in grams per deciliter | 2 weeks of assigned intervention |
| Red cell distribution width | Red cell distribution width as part of a complete blood count panel measured as a percentage | baseline |
| Red cell distribution width | Red cell distribution width as part of a complete blood count panel measured as a percentage | 2 weeks of assigned intervention |
| Platelets | Platelets as part of a complete blood count panel measured as a count per 1000 per microliter | baseline |
| Platelets | Platelets as part of a complete blood count panel measured as a count per 1000 per microliter | 2 weeks of assigned intervention |
| Specific gravity | Specific gravity as measured as part of urinalysis (no units) | baseline |
| Specific gravity | Specific gravity as measured as part of urinalysis (no units) | 2 weeks of assigned intervention |
| pH | pH as measured as part of urinalysis (no units) | baseline |
| pH | pH as measured as part of urinalysis (no units) | 2 weeks of assigned intervention |
| Urine color | Urine color as reported as part of urinalysis (no units) | baseline |
| Urine color | Urine color as reported as part of urinalysis (no units) | 2 weeks of assigned intervention |
| Urine Appearance | Urine Appearance as reported as part of urinalysis (no units) | baseline |
| Urine Appearance | Urine Appearance as reported as part of urinalysis (no units) | 2 weeks of assigned intervention |
| White Blood Cell esterase | White blood cell esterase as measured as part of urinalysis, if present | baseline |
| White blood cell esterase | White blood cell esterase as measured as part of urinalysis, if present | 2 weeks of assigned intervention |
| Protein | Protein as measured as part of urinalysis, if present | baseline |
| Protein | Protein as measured as part of urinalysis, if present | 2 weeks of assigned intervention |
| Glucose | Glucose as measured as part of urinalysis, if present | baseline |
| Glucose | Glucose as measured as part of urinalysis, if present | 2 weeks of assigned intervention |
| Ketones | Ketones as measured as part of urinalysis, if present | baseline |
| Ketones | Ketones as measured as part of urinalysis, if present | 2 weeks of assigned intervention |
| Occult blood | Occult blood as measured as part of urinalysis, if present | baseline |
| Occult blood | Occult blood as measured as part of urinalysis, if present | 2 weeks of assigned intervention |
| Bilirubin | Bilirubin as measured as part of urinalysis, if present | baseline |
| Bilirubin | Bilirubin as measured as part of urinalysis, if present | 2 weeks of assigned intervention |
| Urobilinogen | Urobilinogen as measured as part of urinalysis in milligrams per deciliter | baseline |
| Urobilinogen | Urobilinogen as measured as part of urinalysis in milligrams per deciliter | 2 weeks of assigned intervention |
| Microscopic examination | Microscopic examination as reported as part of urinalysis, if indicated | baseline |
| Microscopic examination | Microscopic examination as reported as part of urinalysis, if indicated | 2 weeks of assigned intervention |
| Total Cholesterol | Total Cholesterol as reported as part of lipid panel in milligrams per deciliter | baseline |
| Total Cholesterol | Total Cholesterol as reported as part of lipid panel in milligrams per deciliter | 2 weeks of assigned intervention |
| Triglycerides | Triglycerides as reported as part of lipid panel in milligrams per deciliter | baseline |
| Triglycerides | Triglycerides as reported as part of lipid panel in milligrams per deciliter | 2 weeks of assigned intervention |
| High-Density Lipoprotein Cholesterol | High-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter | baseline |
| High-Density Lipoprotein Cholesterol | High-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter | 2 weeks of assigned intervention |
| Very Low-Density Lipoprotein Cholesterol | Very Low-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter | baseline |
| Very Low-Density Lipoprotein Cholesterol | Very Low-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter | 2 weeks of assigned intervention |
| Low-Density Lipoprotein Cholesterol | Low-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter | baseline |
| Low-Density Lipoprotein Cholesterol | Low-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter | 2 weeks of assigned intervention |
| Mood questionnaire | Visual analog scale used to assess mood (attentive, tired, alert, groggy, focused, sluggish, energetic, lethargic, fatigued, mental clarity, motivation, happiness, and feeling from 0 (None) to 10 (Extreme) as well as "Flushed out" from 0 (not at all) to 10 (completely empty) | baseline |
| Mood questionnaire | Visual analog scale used to assess mood (attentive, tired, alert, groggy, focused, sluggish, energetic, lethargic, fatigued, mental clarity, motivation, happiness, and feeling from 0 (None) to 10 (Extreme) as well as "Flushed out" from 0 (not at all) to 10 (completely empty) | 2 weeks of assigned intervention |
| 36-item short form survey | 36-item questionnaire that measures health-related quality of life with responses used to calculate scores on a scale of 0-100, where higher scores indicate better health. | baseline |
| 36-item short form survey | 36-item questionnaire that measures health-related quality of life with responses used to calculate scores on a scale of 0-100, where higher scores indicate better health. | 2 weeks of assigned intervention |
| Tolerability Questionnaire | 18 item questionnaire covering upper abdominal, lower abdominal, and other symptoms using a 0-9 scale (0-no problem at all to 9-the worst it has ever been) | baseline |
| Tolerability Questionnaire | 18 item questionnaire covering upper abdominal, lower abdominal, and other symptoms using a 0-9 scale (0-no problem at all to 9-the worst it has ever been) | 1 day of assigned treatment |
| Tolerability Questionnaire | 18 item questionnaire covering upper abdominal, lower abdominal, and other symptoms using a 0-9 scale (0-no problem at all to 9-the worst it has ever been) | 3 days of assigned treatment |
| Tolerability Questionnaire | 18 item questionnaire covering upper abdominal, lower abdominal, and other symptoms using a 0-9 scale (0-no problem at all to 9-the worst it has ever been) | 1 week of assigned treatment |
| Tolerability Questionnaire | 18 item questionnaire covering upper abdominal, lower abdominal, and other symptoms using a 0-9 scale (0-no problem at all to 9-the worst it has ever been) | 2 weeks of assigned treatment |
| Bristol Chart | Self-reported number and consistency of daily bowel movements | 3 days before baseline |
| Bristol Chart | Self-reported number and consistency of daily bowel movements | 2 days before baseline |
| Bristol Chart | Self-reported number and consistency of daily bowel movements | 1 day before baseline |
| Bristol Chart | Self-reported number and consistency of daily bowel movements | 1 day of assigned treatment |
| Bristol Chart | Self-reported number and consistency of daily bowel movements | 2 days on assigned treatment |
| Bristol Chart | Self-reported number and consistency of daily bowel movements | 3 days of assigned treatment |
| Bristol Chart | Self-reported number and consistency of daily bowel movements | 7 days of assigned treatment |
| Bristol Chart | Self-reported number and consistency of daily bowel movements | 14 days of assigned treatment |
| Weight | Body weight measured in kg | baseline |
| Weight | Body weight measured in kg | 2 weeks of assigned treatment |
| Skin age | a quantitative skin age based on skin parameters will be determined by the 3D P Plus system | baseline |
| Skin age | a quantitative skin age based on skin parameters will be determined by the 3D P Plus system | 2 weeks of assigned treatment |
| Diastolic blood pressure | Diastolic blood pressure will be measured using an automated blood pressure machine in units millimeters of mercury | baseline |
| Diastolic blood pressure | Diastolic blood pressure will be measured using an automated blood pressure machine in units millimeters of mercury | 2 weeks of assigned treatment |
| Systolic blood pressure | Systolic blood pressure will be measured using an automated blood pressure machine in units millimeters of mercury | baseline |
| Systolic blood pressure | Systolic blood pressure will be measured using an automated blood pressure machine in units millimeters of mercury | 2 weeks of assigned treatment |
| Heart rate | Heart rate will be measured using an automated blood pressure machine in units beats per minute | baseline |
| Heart Rate | Hear rate will be measured using an automated blood pressure machine in units beats per minute | 2 weeks of assigned treatment |
| 2 days prior to baseline visit |
| Daily food diary | Daily food diary of all food and drink consumed that day | 1 day prior to baseline visit |
| Daily food diary | Daily food diary of all food and drink consumed that day | 3 days prior to 2 week visit |
| Daily food diary | Daily food diary of all food and drink consumed that day | 2 days prior to 2 week visit |
| Daily food diary | Daily food diary of all food and drink consumed that day | 1 day prior to 2 week visit |