Impact of the Inno Cleanse Dietary Supplement on Gut Health and Associated Variables in Healthy Men and Women
Part of paid clinical trials in Memphis, Tennessee.
- Sponsor
- University of Memphis
- Study ID
- NCT07215351
- Status
- Recruiting
Conditions
- Bloating
- Constipation
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Dietary supplement for digestive health — DIETARY_SUPPLEMENTDietary 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.
- placebo capsule — DIETARY_SUPPLEMENTContains hydroxypropyl methylcellulose and cellulose
Study Details
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.
Key Dates
- Start date
- Oct 7, 2025
- Status verified
- Apr 2026
- Primary completion
- May 1, 2026
- Completion
- May 1, 2026
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Experimental Dietary Supplement15 randomly assigned individuals will receive 2 capsules daily of the experimental dietary supplement for 2 weeks with assessments prior and after intervention.
- Placebo Comparator: Placebo Control15 randomly assigned individuals will receive 2 capsules daily of the placebo for 2 weeks with assessments prior and after intervention.
Primary Outcome Measure
Alanine transaminase [ Time Frame: baseline ]
Central Contacts
- Jacquelyn Pence, PhD901-678-1547
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Center for Nutraceutical and Dietary Supplement Research | Memphis | Tennessee | 38152 |
Find similar trials in Memphis, TN
Related Studies
- Understanding Mechanisms of Normal and Disordered DefecationRecruiting · Mayo Clinic · Rochester, Minnesota
- Indiana University Gastrointestinal Motility Diagnosis RegistryRecruiting · Indiana University · Indianapolis, Indiana
- Pyridostigmine for the Treatment of Constipation in Parkinson DiseasePHASE2 · Recruiting · University of Vermont Medical Center · Burlington, Vermont
- Preop Laxatives in Robotic Urologic SurgeryPHASE4 · Recruiting · Chad R. Tracy · Iowa City, Iowa