Status:
RECRUITING
Impact of the Inno Cleanse Dietary Supplement on Gut Health and Associated Variables in Healthy Men and Women
Lead Sponsor:
University of Memphis
Collaborating Sponsors:
INNOSUPPS
Conditions:
Constipation
Bloating
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 f...
Eligibility Criteria
Inclusion
- experience regular (2 or more days per week) bloating or constipation
- able to fast a minimum of 12 hours prior to testing visit
Exclusion
- 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
Key Trial Info
Start Date :
October 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07215351
Start Date
October 7 2025
End Date
January 1 2026
Last Update
October 14 2025
Active Locations (1)
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1
Center for Nutraceutical and Dietary Supplement Research
Memphis, Tennessee, United States, 38152