RecruitingNot Applicable

Impact of the Inno Cleanse Dietary Supplement on Gut Health and Associated Variables in Healthy Men and Women

United States30 participantsStarted 2025-10-07

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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-lo…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Alanine transaminase

Timeframe: baseline

Alanine transaminase

Timeframe: 2 weeks of assigned intervention

Aspartate transferase

Timeframe: baseline

Aspartate transferase

Timeframe: 2 weeks of assigned intervention

Albumin

Timeframe: baseline

Albumin

Timeframe: 2 weeks of assigned intervention

Alkaline phosphatase

Timeframe: baseline

Alkaline phosphatase

Timeframe: 2 weeks of assigned intervention

Trial details

NCT IDNCT07215351

SponsorUniversity of Memphis

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-01

Contact for this trial

Jacquelyn Pence, PhD

901-678-1547 jpence1@memphis.edu

View on ClinicalTrials.gov More Constipation trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Alanine transaminase

Timeframe: baseline

Alanine transaminase

Timeframe: 2 weeks of assigned intervention

Aspartate transferase

Timeframe: baseline

Aspartate transferase

Timeframe: 2 weeks of assigned intervention

Albumin

Timeframe: baseline

Albumin

Timeframe: 2 weeks of assigned intervention

Alkaline phosphatase

Timeframe: baseline

Alkaline phosphatase

Timeframe: 2 weeks of assigned intervention