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 range18 Years

SexALL

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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…

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

Total bilirubin

Timeframe: baseline

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 range18 Years

SexALL

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

Total bilirubin

Timeframe: baseline