Impact of the Inno Cleanse™ Dietary Supplement on Gut Health and Associated Variables in Healthy Men and Women
- Conditions
- ConstipationBloating
- Registration Number
- NCT07215351
- Lead Sponsor
- University of Memphis
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- experience regular (2 or more days per week) bloating or constipation
- able to fast a minimum of 12 hours prior to testing visit
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Alanine transaminase 2 weeks of assigned intervention Alanine transaminase measured as part of metabolic panel in international units per liter
Aspartate transferase 2 weeks of assigned intervention Aspartate transferase measured as part of metabolic panel in international units per liter
Albumin 2 weeks of assigned intervention Albumin measured as part of metabolic panel in grams per deciliter
Alkaline phosphatase 2 weeks of assigned intervention Alkaline phosphatase measured as part of metabolic panel in international units per liter
Total bilirubin baseline Total bilirubin measured as part of metabolic panel in milligrams per deciliter
Total Bilirubin 2 weeks of assigned intervention Total bilirubin measured as part of metabolic panel in milligrams per deciliter
Blood urea nitrogen 2 weeks of assigned intervention Blood urea nitrogen measured as part of metabolic panel in milligrams per deciliter
Calcium 2 weeks of assigned intervention Calcium measured as part of metabolic panel in milligrams per deciliter
Carbon dioxide 2 weeks of assigned intervention Carbon dioxide measured as part of metabolic panel in millimoles per liter
Chloride 2 weeks of assigned intervention Chloride measured as part of metabolic panel in millimoles per liter.
Creatinine 2 weeks of assigned intervention Creatinine measured as part of metabolic panel in milligrams per deciliter
Estimated glomerular filtration rate 2 weeks of assigned intervention Estimated glomerular filtration rate as part of metabolic panel in milliliters per minute per 1.73
Blood Glucose 2 weeks of assigned intervention Glucose measured as part of metabolic panel in milligrams per deciliter
Potassium 2 weeks of assigned intervention Potassium measured as part of metabolic panel in millimoles per liter.
Sodium 2 weeks of assigned intervention Sodium measured as part of metabolic panel in millimoles per liter.
Total Globulin 2 weeks of assigned intervention Total Globulin measured as part of metabolic panel in grams per deciliter
Total Protein 2 weeks of assigned intervention Total Protein measured as part of metabolic panel in grams per deciliter
Albumin/globulin ratio 2 weeks of assigned intervention Albumin/globulin ratio measured as part of metabolic panel
Blood urea nitrogen/creatinine ratio 2 weeks of assigned intervention Blood urea nitrogen/creatinine ratio measured as part of metabolic panel
Hematocrit 2 weeks of assigned intervention Hematocrit as part of a complete blood count panel measured as percentage
Hemoglobin 2 weeks of assigned intervention Hemoglobin as part of a complete blood count panel measured in grams per deciliter
Mean corpuscular volume 2 weeks of assigned intervention Mean corpuscular volume as part of a complete blood count panel measured in femtoliters
Mean corpuscular hemoglobin 2 weeks of assigned intervention Mean corpuscular hemoglobin as part of a complete blood count panel measured in picograms
Mean corpuscular hemoglobin concentration 2 weeks of assigned intervention Mean corpuscular hemoglobin concentration as part of a complete blood count panel measured in grams per deciliter
Red cell distribution width 2 weeks of assigned intervention Red cell distribution width as part of a complete blood count panel measured as a percentage
Platelets 2 weeks of assigned intervention Platelets as part of a complete blood count panel measured as a count per 1000 per microliter
Specific gravity 2 weeks of assigned intervention Specific gravity as measured as part of urinalysis (no units)
pH 2 weeks of assigned intervention pH as measured as part of urinalysis (no units)
Urine color 2 weeks of assigned intervention Urine color as reported as part of urinalysis (no units)
Urine Appearance 2 weeks of assigned intervention Urine Appearance as reported as part of urinalysis (no units)
White Blood Cell esterase baseline White blood cell esterase as measured as part of urinalysis, if present
White blood cell esterase 2 weeks of assigned intervention White blood cell esterase as measured as part of urinalysis, if present
Protein 2 weeks of assigned intervention Protein as measured as part of urinalysis, if present
Glucose 2 weeks of assigned intervention Glucose as measured as part of urinalysis, if present
Ketones 2 weeks of assigned intervention Ketones as measured as part of urinalysis, if present
Occult blood 2 weeks of assigned intervention Occult blood as measured as part of urinalysis, if present
Bilirubin 2 weeks of assigned intervention Bilirubin as measured as part of urinalysis, if present
Urobilinogen 2 weeks of assigned intervention Urobilinogen as measured as part of urinalysis in milligrams per deciliter
Microscopic examination 2 weeks of assigned intervention Microscopic examination as reported as part of urinalysis, if indicated
Total Cholesterol 2 weeks of assigned intervention Total Cholesterol as reported as part of lipid panel in milligrams per deciliter
Triglycerides 2 weeks of assigned intervention Triglycerides as reported as part of lipid panel in milligrams per deciliter
High-Density Lipoprotein Cholesterol 2 weeks of assigned intervention High-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter
Very Low-Density Lipoprotein Cholesterol 2 weeks of assigned intervention Very Low-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter
Low-Density Lipoprotein Cholesterol 2 weeks of assigned intervention Low-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter
Mood questionnaire 2 weeks of assigned intervention Visual analog scale used to assess mood (attentive, tired, alert, groggy, focused, sluggish, energetic, lethargic, fatigued, mental clarity, motivation, happiness, and feeling from 0 (None) to 10 (Extreme) as well as "Flushed out" from 0 (not at all) to 10 (completely empty)
36-item short form survey 2 weeks of assigned intervention 36-item questionnaire that measures health-related quality of life with responses used to calculate scores on a scale of 0-100, where higher scores indicate better health.
Tolerability Questionnaire 2 weeks of assigned treatment 18 item questionnaire covering upper abdominal, lower abdominal, and other symptoms using a 0-9 scale (0-no problem at all to 9-the worst it has ever been)
Bristol Chart 14 days of assigned treatment Self-reported number and consistency of daily bowel movements
Weight 2 weeks of assigned treatment Body weight measured in kg
Skin age 2 weeks of assigned treatment a quantitative skin age based on skin parameters will be determined by the 3D P Plus system
- Secondary Outcome Measures
Name Time Method Daily food diary 1 day prior to 2 week visit Daily food diary of all food and drink consumed that day
Trial Locations
- Locations (1)
Center for Nutraceutical and Dietary Supplement Research
🇺🇸Memphis, Tennessee, United States
Center for Nutraceutical and Dietary Supplement Research🇺🇸Memphis, Tennessee, United StatesJacquelyn Pence, PhDContact901-678-1547jpence1@memphis.edu