Bloating, Constipation
Conditions
Keywords
Inno Cleanse
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.
Interventions
DIETARY_SUPPLEMENTDietary supplement for digestive health
Dietary 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.
DIETARY_SUPPLEMENTplacebo capsule
Contains hydroxypropyl methylcellulose and cellulose
Sponsors
University of Memphis
INNOSUPPS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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-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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alanine transaminase | baseline | Alanine transaminase measured as part of metabolic panel in international units per liter |
| Aspartate transferase | baseline | Aspartate transferase measured as part of metabolic panel in international units per liter |
| Albumin | baseline | Albumin measured as part of metabolic panel in grams per deciliter |
| Alkaline phosphatase | baseline | 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 | baseline | Blood urea nitrogen measured as part of metabolic panel in milligrams per deciliter |
| Calcium | baseline | Calcium measured as part of metabolic panel in milligrams per deciliter |
| Carbon dioxide | baseline | Carbon dioxide measured as part of metabolic panel in millimoles per liter |
| Chloride | baseline | Chloride measured as part of metabolic panel in millimoles per liter. |
| Creatinine | baseline | Creatinine measured as part of metabolic panel in milligrams per deciliter |
| Estimated glomerular filtration rate | baseline | Estimated glomerular filtration rate as part of metabolic panel in milliliters per minute per 1.73 |
| Blood Glucose | baseline | Glucose measured as part of metabolic panel in milligrams per deciliter |
| Potassium | baseline | Potassium measured as part of metabolic panel in millimoles per liter. |
| Sodium | baseline | Sodium measured as part of metabolic panel in millimoles per liter. |
| Total Globulin | baseline | Total Globulin measured as part of metabolic panel in grams per deciliter |
| Total Protein | baseline | Total Protein measured as part of metabolic panel in grams per deciliter |
| Albumin/globulin ratio | baseline | Albumin/globulin ratio measured as part of metabolic panel |
| Blood urea nitrogen/creatinine ratio | baseline | Blood urea nitrogen/creatinine ratio measured as part of metabolic panel |
| Hematocrit | baseline | Hematocrit as part of a complete blood count panel measured as percentage |
| Hemoglobin | baseline | Hemoglobin as part of a complete blood count panel measured in grams per deciliter |
| Mean corpuscular volume | baseline | Mean corpuscular volume as part of a complete blood count panel measured in femtoliters |
| Mean corpuscular hemoglobin | baseline | Mean corpuscular hemoglobin as part of a complete blood count panel measured in picograms |
| Mean corpuscular hemoglobin concentration | baseline | Mean corpuscular hemoglobin concentration as part of a complete blood count panel measured in grams per deciliter |
| Red cell distribution width | baseline | Red cell distribution width as part of a complete blood count panel measured as a percentage |
| Platelets | baseline | Platelets as part of a complete blood count panel measured as a count per 1000 per microliter |
| Specific gravity | baseline | Specific gravity as measured as part of urinalysis (no units) |
| pH | baseline | pH as measured as part of urinalysis (no units) |
| Urine color | baseline | Urine color as reported as part of urinalysis (no units) |
| Urine Appearance | baseline | 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 | baseline | Protein as measured as part of urinalysis, if present |
| Glucose | baseline | Glucose as measured as part of urinalysis, if present |
| Ketones | baseline | Ketones as measured as part of urinalysis, if present |
| Occult blood | baseline | Occult blood as measured as part of urinalysis, if present |
| Bilirubin | baseline | Bilirubin as measured as part of urinalysis, if present |
| Urobilinogen | baseline | Urobilinogen as measured as part of urinalysis in milligrams per deciliter |
| Microscopic examination | baseline | Microscopic examination as reported as part of urinalysis, if indicated |
| Total Cholesterol | baseline | Total Cholesterol as reported as part of lipid panel in milligrams per deciliter |
| Triglycerides | baseline | Triglycerides as reported as part of lipid panel in milligrams per deciliter |
| High-Density Lipoprotein Cholesterol | baseline | High-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter |
| Very Low-Density Lipoprotein Cholesterol | baseline | Very Low-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter |
| Low-Density Lipoprotein Cholesterol | baseline | Low-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter |
| Mood questionnaire | baseline | 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 | baseline | 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 | baseline | 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 | 3 days before baseline | Self-reported number and consistency of daily bowel movements |
| Weight | baseline | Body weight measured in kg |
| Skin age | baseline | a quantitative skin age based on skin parameters will be determined by the 3D P Plus system |
| Diastolic blood pressure | baseline | Diastolic blood pressure will be measured using an automated blood pressure machine in units millimeters of mercury |
| Systolic blood pressure | baseline | Systolic blood pressure will be measured using an automated blood pressure machine in units millimeters of mercury |
| Heart rate | baseline | Heart rate will be measured using an automated blood pressure machine in units beats per minute |
| Heart Rate | 2 weeks of assigned treatment | Hear rate will be measured using an automated blood pressure machine in units beats per minute |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily food diary | 3 days prior to baseline visit | Daily food diary of all food and drink consumed that day |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRichard Bloomer, PhD
University of Memphis
Outcome results
None listed