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

NCT07215351 | Recruiting

• 1 other identifier: PRO-FY2025-554
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Bloating; Constipation

Keywords

Inno Cleanse

Outcome Measures

Primary Outcomes (111)

• Alanine transaminase

  Alanine transaminase measured as part of metabolic panel in international units per liter

  baseline

• Alanine transaminase

  Alanine transaminase measured as part of metabolic panel in international units per liter

  2 weeks of assigned intervention

• Aspartate transferase

  Aspartate transferase measured as part of metabolic panel in international units per liter

  baseline

• Aspartate transferase

  Aspartate transferase measured as part of metabolic panel in international units per liter

  2 weeks of assigned intervention

• Albumin

  Albumin measured as part of metabolic panel in grams per deciliter

  baseline

• Albumin

  Albumin measured as part of metabolic panel in grams per deciliter

  2 weeks of assigned intervention

• Alkaline phosphatase

  Alkaline phosphatase measured as part of metabolic panel in international units per liter

  baseline

• Alkaline phosphatase

  Alkaline phosphatase measured as part of metabolic panel in international units per liter

  2 weeks of assigned intervention

• Total bilirubin

  Total bilirubin measured as part of metabolic panel in milligrams per deciliter

  baseline

• Total Bilirubin

  Total bilirubin measured as part of metabolic panel in milligrams per deciliter

  2 weeks of assigned intervention

• Blood urea nitrogen

  Blood urea nitrogen measured as part of metabolic panel in milligrams per deciliter

  baseline

• Blood urea nitrogen

  Blood urea nitrogen measured as part of metabolic panel in milligrams per deciliter

  2 weeks of assigned intervention

• Calcium

  Calcium measured as part of metabolic panel in milligrams per deciliter

  baseline

• Calcium

  Calcium measured as part of metabolic panel in milligrams per deciliter

  2 weeks of assigned intervention

• Carbon dioxide

  Carbon dioxide measured as part of metabolic panel in millimoles per liter

  baseline

• Carbon dioxide

  Carbon dioxide measured as part of metabolic panel in millimoles per liter

  2 weeks of assigned intervention

• Chloride

  Chloride measured as part of metabolic panel in millimoles per liter.

  baseline

• Chloride

  Chloride measured as part of metabolic panel in millimoles per liter.

  2 weeks of assigned intervention

• Creatinine

  Creatinine measured as part of metabolic panel in milligrams per deciliter

  baseline

• Creatinine

  Creatinine measured as part of metabolic panel in milligrams per deciliter

  2 weeks of assigned intervention

• Estimated glomerular filtration rate

  Estimated glomerular filtration rate as part of metabolic panel in milliliters per minute per 1.73

  baseline

• Estimated glomerular filtration rate

  Estimated glomerular filtration rate as part of metabolic panel in milliliters per minute per 1.73

  2 weeks of assigned intervention

• Blood Glucose

  Glucose measured as part of metabolic panel in milligrams per deciliter

  baseline

• Blood Glucose

  Glucose measured as part of metabolic panel in milligrams per deciliter

  2 weeks of assigned intervention

• Potassium

  Potassium measured as part of metabolic panel in millimoles per liter.

  baseline

• Potassium

  Potassium measured as part of metabolic panel in millimoles per liter.

  2 weeks of assigned intervention

• Sodium

  Sodium measured as part of metabolic panel in millimoles per liter.

  baseline

• Sodium

  Sodium measured as part of metabolic panel in millimoles per liter.

  2 weeks of assigned intervention

• Total Globulin

  Total Globulin measured as part of metabolic panel in grams per deciliter

  baseline

• Total Globulin

  Total Globulin measured as part of metabolic panel in grams per deciliter

  2 weeks of assigned intervention

• Total Protein

  Total Protein measured as part of metabolic panel in grams per deciliter

  baseline

• Total Protein

  Total Protein measured as part of metabolic panel in grams per deciliter

  2 weeks of assigned intervention

• Albumin/globulin ratio

  Albumin/globulin ratio measured as part of metabolic panel

  baseline

• Albumin/globulin ratio

  Albumin/globulin ratio measured as part of metabolic panel

  2 weeks of assigned intervention

• Blood urea nitrogen/creatinine ratio

  Blood urea nitrogen/creatinine ratio measured as part of metabolic panel

  baseline

• Blood urea nitrogen/creatinine ratio

  Blood urea nitrogen/creatinine ratio measured as part of metabolic panel

  2 weeks of assigned intervention

• Hematocrit

  Hematocrit as part of a complete blood count panel measured as percentage

  baseline

• Hematocrit

  Hematocrit as part of a complete blood count panel measured as percentage

  2 weeks of assigned intervention

• Hemoglobin

  Hemoglobin as part of a complete blood count panel measured in grams per deciliter

  baseline

• Hemoglobin

  Hemoglobin as part of a complete blood count panel measured in grams per deciliter

  2 weeks of assigned intervention

• Mean corpuscular volume

  Mean corpuscular volume as part of a complete blood count panel measured in femtoliters

  baseline

• Mean corpuscular volume

  Mean corpuscular volume as part of a complete blood count panel measured in femtoliters

  2 weeks of assigned intervention

• Mean corpuscular hemoglobin

  Mean corpuscular hemoglobin as part of a complete blood count panel measured in picograms

  baseline

• Mean corpuscular hemoglobin

  Mean corpuscular hemoglobin as part of a complete blood count panel measured in picograms

  2 weeks of assigned intervention

• Mean corpuscular hemoglobin concentration

  Mean corpuscular hemoglobin concentration as part of a complete blood count panel measured in grams per deciliter

  baseline

• Mean corpuscular hemoglobin concentration

  Mean corpuscular hemoglobin concentration as part of a complete blood count panel measured in grams per deciliter

  2 weeks of assigned intervention

• Red cell distribution width

  Red cell distribution width as part of a complete blood count panel measured as a percentage

  baseline

• Red cell distribution width

  Red cell distribution width as part of a complete blood count panel measured as a percentage

  2 weeks of assigned intervention

• Platelets

  Platelets as part of a complete blood count panel measured as a count per 1000 per microliter

  baseline

• Platelets

  Platelets as part of a complete blood count panel measured as a count per 1000 per microliter

  2 weeks of assigned intervention

• Specific gravity

  Specific gravity as measured as part of urinalysis (no units)

  baseline

• Specific gravity

  Specific gravity as measured as part of urinalysis (no units)

  2 weeks of assigned intervention

• pH

  pH as measured as part of urinalysis (no units)

  baseline

• pH

  pH as measured as part of urinalysis (no units)

  2 weeks of assigned intervention

• Urine color

  Urine color as reported as part of urinalysis (no units)

  baseline

• Urine color

  Urine color as reported as part of urinalysis (no units)

  2 weeks of assigned intervention

• Urine Appearance

  Urine Appearance as reported as part of urinalysis (no units)

  baseline

• Urine Appearance

  Urine Appearance as reported as part of urinalysis (no units)

  2 weeks of assigned intervention

• White Blood Cell esterase

  White blood cell esterase as measured as part of urinalysis, if present

  baseline

• White blood cell esterase

  White blood cell esterase as measured as part of urinalysis, if present

  2 weeks of assigned intervention

• Protein

  Protein as measured as part of urinalysis, if present

  baseline

• Protein

  Protein as measured as part of urinalysis, if present

  2 weeks of assigned intervention

• Glucose

  Glucose as measured as part of urinalysis, if present

  baseline

• Glucose

  Glucose as measured as part of urinalysis, if present

  2 weeks of assigned intervention

• Ketones

  Ketones as measured as part of urinalysis, if present

  baseline

• Ketones

  Ketones as measured as part of urinalysis, if present

  2 weeks of assigned intervention

• Occult blood

  Occult blood as measured as part of urinalysis, if present

  baseline

• Occult blood

  Occult blood as measured as part of urinalysis, if present

  2 weeks of assigned intervention

• Bilirubin

  Bilirubin as measured as part of urinalysis, if present

  baseline

• Bilirubin

  Bilirubin as measured as part of urinalysis, if present

  2 weeks of assigned intervention

• Urobilinogen

  Urobilinogen as measured as part of urinalysis in milligrams per deciliter

  baseline

• Urobilinogen

  Urobilinogen as measured as part of urinalysis in milligrams per deciliter

  2 weeks of assigned intervention

• Microscopic examination

  Microscopic examination as reported as part of urinalysis, if indicated

  baseline

• Microscopic examination

  Microscopic examination as reported as part of urinalysis, if indicated

  2 weeks of assigned intervention

• Total Cholesterol

  Total Cholesterol as reported as part of lipid panel in milligrams per deciliter

  baseline

• Total Cholesterol

  Total Cholesterol as reported as part of lipid panel in milligrams per deciliter

  2 weeks of assigned intervention

• Triglycerides

  Triglycerides as reported as part of lipid panel in milligrams per deciliter

  baseline

• Triglycerides

  Triglycerides as reported as part of lipid panel in milligrams per deciliter

  2 weeks of assigned intervention

• High-Density Lipoprotein Cholesterol

  High-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter

  baseline

• High-Density Lipoprotein Cholesterol

  High-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter

  2 weeks of assigned intervention

• Very Low-Density Lipoprotein Cholesterol

  Very Low-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter

  baseline

• Very Low-Density Lipoprotein Cholesterol

  Very Low-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter

  2 weeks of assigned intervention

• Low-Density Lipoprotein Cholesterol

  Low-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter

  baseline

• Low-Density Lipoprotein Cholesterol

  Low-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter

  2 weeks of assigned intervention

• Mood questionnaire

  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)

  baseline

• Mood questionnaire

  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)

  2 weeks of assigned intervention

• 36-item short form survey

  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.

  baseline

• 36-item short form survey

  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.

  2 weeks of assigned intervention

• Tolerability Questionnaire

  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)

  baseline

• Tolerability Questionnaire

  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)

  1 day of assigned treatment

• Tolerability Questionnaire

  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)

  3 days of assigned treatment

• Tolerability Questionnaire

  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)

  1 week of assigned treatment

• Tolerability Questionnaire

  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)

  2 weeks of assigned treatment

• Bristol Chart

  Self-reported number and consistency of daily bowel movements

  3 days before baseline

• Bristol Chart

  Self-reported number and consistency of daily bowel movements

  2 days before baseline

• Bristol Chart

  Self-reported number and consistency of daily bowel movements

  1 day before baseline

• Bristol Chart

  Self-reported number and consistency of daily bowel movements

  1 day of assigned treatment

• Bristol Chart

  Self-reported number and consistency of daily bowel movements

  2 days on assigned treatment

• Bristol Chart

  Self-reported number and consistency of daily bowel movements

  3 days of assigned treatment

• Bristol Chart

  Self-reported number and consistency of daily bowel movements

  7 days of assigned treatment

• Bristol Chart

  Self-reported number and consistency of daily bowel movements

  14 days of assigned treatment

• Weight

  Body weight measured in kg

  baseline

• Weight

  Body weight measured in kg

  2 weeks of assigned treatment

• Skin age

  a quantitative skin age based on skin parameters will be determined by the 3D P Plus system

  baseline

• Skin age

  a quantitative skin age based on skin parameters will be determined by the 3D P Plus system

  2 weeks of assigned treatment

• Diastolic blood pressure

  Diastolic blood pressure will be measured using an automated blood pressure machine in units millimeters of mercury

  baseline

• Diastolic blood pressure

  Diastolic blood pressure will be measured using an automated blood pressure machine in units millimeters of mercury

  2 weeks of assigned treatment

• Systolic blood pressure

  Systolic blood pressure will be measured using an automated blood pressure machine in units millimeters of mercury

  baseline

• Systolic blood pressure

  Systolic blood pressure will be measured using an automated blood pressure machine in units millimeters of mercury

  2 weeks of assigned treatment

• Heart rate

  Heart rate will be measured using an automated blood pressure machine in units beats per minute

  baseline

• Heart Rate

  Hear rate will be measured using an automated blood pressure machine in units beats per minute

  2 weeks of assigned treatment

Secondary Outcomes (6)

• Daily food diary

  3 days prior to baseline visit

• Daily food diary

  2 days prior to baseline visit

• Daily food diary

  1 day prior to baseline visit

• Daily food diary

  3 days prior to 2 week visit

• Daily food diary

  2 days prior to 2 week visit

Study Arms (2)

Experimental Dietary Supplement

EXPERIMENTAL

15 randomly assigned individuals will receive 2 capsules daily of the experimental dietary supplement for 2 weeks with assessments prior and after intervention.

Dietary Supplement: Dietary supplement for digestive health

Placebo Control

PLACEBO COMPARATOR

15 randomly assigned individuals will receive 2 capsules daily of the placebo for 2 weeks with assessments prior and after intervention.

Dietary Supplement: placebo capsule

Interventions

Dietary supplement for digestive health DIETARY_SUPPLEMENT

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.

Experimental Dietary Supplement

placebo capsule DIETARY_SUPPLEMENT

Contains hydroxypropyl methylcellulose and cellulose

Placebo Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• experience regular (2 or more days per week) bloating or constipation
• able to fast a minimum of 12 hours prior to testing visit

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Memphis: lead
• INNOSUPPS: collaborator

Study Sites (1)

Center for Nutraceutical and Dietary Supplement Research

Memphis, Tennessee, 38152, United States

RECRUITING

MeSH Terms

Conditions

Constipation

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Richard Bloomer, PhD

  University of Memphis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacquelyn Pence, PhD

CONTACT

901-678-1547; jpence1@memphis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of College of Health Sciences

Study Record Dates

• First Submitted: October 8, 2025
• First Posted: October 10, 2025
• Study Start: October 7, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-04

Locations

US (1)