Inno Cleanse for reducing bloating in healthy adults
Impact of the Inno Cleanse Dietary Supplement on Gut Health and Associated Variables in Healthy Men and Women
This study will see if taking the Inno Cleanse dietary supplement helps reduce bloating in otherwise healthy adults who frequently feel bloated.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Memphis Academic / other |
| Locations | 1 site (Memphis, Tennessee) |
| Trial ID | NCT07215351 on ClinicalTrials.gov |
What this trial studies
Adults who report regular bloating or constipation will receive either the Inno Cleanse dietary supplement or a placebo capsule and be followed during scheduled clinic visits. Participants are screened to exclude pregnancy, diagnosed gastrointestinal diseases, diabetes, hypertension, regular diarrhea, active infection, or allergies to product ingredients, and must fast before testing visits. Outcomes include self-reported bloating and constipation measures and other gut-health variables collected at the research center. The product is manufactured under cGMP and widely sold, but clinical evidence for this specific combined supplement is limited.
Who should consider this trial
Good fit: Adults who experience bloating or constipation at least two days per week, are otherwise healthy, not pregnant or breastfeeding, not diabetic or hypertensive, and can attend in-person visits and fast as required are the intended participants.
Not a fit: People with diagnosed gastrointestinal disorders (such as celiac disease, Crohn's disease, IBS, ulcerative colitis), regular diarrhea, diabetes, hypertension, pregnancy, breastfeeding, or known allergies to the product ingredients are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, this could offer an over-the-counter option to reduce bloating and improve digestive comfort in people without diagnosed GI disease.
How similar studies have performed: Some individual ingredients in the product have supportive evidence for digestive effects, but randomized clinical data on this specific combined supplement are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * experience regular (2 or more days per week) bloating or constipation * able to fast a minimum of 12 hours prior to testing visit Exclusion Criteria: * pregnant, planning to become pregnant, or breastfeeding * sensitivity or allergic to any components of the study product (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, cellulose, and silicon dioxide). * experienced a severe allergic reaction that resulted in emergency care * diagnosed with medical disorders linked to digestive/gut health such as celiac disease, crohn's disease, gastroesophageal reflux disease, heartburn, irritable bowel syndrome, ulcerative colitis, ulcers, etcetera. * experiencing regular diarrhea * active infection or illness * diabetic * hypertensive * cardiovascular disease * breast, uterine, or ovarian cancer * uterine fibroids or endometriosis * taking medications or supplements that may alter gut health including but not limited to diuretics, laxatives, anti-diarrheal, anticholinergic agents, or antispasmodic agents. * previous adverse experience with laxatives * taking medications known to interact with the dietary supplement's ingredients including blood pressure medications, anticoagulants, antiplatelets, blood thinners, cholesterol-lowering medications, diuretics, water pills, estrogen based contraceptives, non-steroidal anti-inflammatory drugs, digoxin, corticosteroids, Monoamine oxidase inhibitors, insulin, medications processed in the liver, diclofenac, fluvastatin, glipizide, ibuprofen, piroxicam, phenytoin, phenobarbital, or secobarbital. * tobacco user * strenuous activity within 24 hours of testing visits * caffeine within 24 hours of testing visit * alcohol within 24 hours of testing visit
Where this trial is running
Memphis, Tennessee
- Center for Nutraceutical and Dietary Supplement Research — Memphis, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Richard Bloomer, PhD — University of Memphis
- Study coordinator: Jacquelyn Pence, PhD
- Email: jpence1@memphis.edu
- Phone: 901-678-1547
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.