Patients are searching for this trial right now

This page is already ranking on Google. Activate it to start receiving pre-qualified patient leads directly in your inbox.

14-day free trial · $44/mo after · Cancel anytime · Money-back guarantee

NCT07215351 · University of Memphis

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

What this study is about

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.

View original scientific description

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_SUPPLEMENT

Dietary 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_SUPPLEMENT

placebo capsule

Contains hydroxypropyl methylcellulose and cellulose

Primary outcome measures

Alanine transaminase

Time frame: baseline

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

Alanine transaminase

Time frame: 2 weeks of assigned intervention

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

Aspartate transferase

Time frame: baseline

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

Aspartate transferase

Time frame: 2 weeks of assigned intervention

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

Albumin

Time frame: baseline

Albumin measured as part of metabolic panel in grams per deciliter

Albumin

Time frame: 2 weeks of assigned intervention

Albumin measured as part of metabolic panel in grams per deciliter

Alkaline phosphatase

Time frame: baseline

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

Alkaline phosphatase

Time frame: 2 weeks of assigned intervention

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

Total bilirubin

Time frame: baseline

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

Total Bilirubin

Time frame: 2 weeks of assigned intervention

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

Blood urea nitrogen

Time frame: baseline

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

Blood urea nitrogen

Time frame: 2 weeks of assigned intervention

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

Calcium

Time frame: baseline

Calcium measured as part of metabolic panel in milligrams per deciliter

Calcium

Time frame: 2 weeks of assigned intervention

Calcium measured as part of metabolic panel in milligrams per deciliter

Carbon dioxide

Time frame: baseline

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

Carbon dioxide

Time frame: 2 weeks of assigned intervention

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

Chloride

Time frame: baseline

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

Chloride

Time frame: 2 weeks of assigned intervention

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

Creatinine

Time frame: baseline

Creatinine measured as part of metabolic panel in milligrams per deciliter

Creatinine

Time frame: 2 weeks of assigned intervention

Creatinine measured as part of metabolic panel in milligrams per deciliter

Estimated glomerular filtration rate

Time frame: baseline

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

Estimated glomerular filtration rate

Time frame: 2 weeks of assigned intervention

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

Blood Glucose

Time frame: baseline

Glucose measured as part of metabolic panel in milligrams per deciliter

Blood Glucose

Time frame: 2 weeks of assigned intervention

Glucose measured as part of metabolic panel in milligrams per deciliter

Potassium

Time frame: baseline

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

Potassium

Time frame: 2 weeks of assigned intervention

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

Sodium

Time frame: baseline

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

Sodium

Time frame: 2 weeks of assigned intervention

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

Total Globulin

Time frame: baseline

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

Total Globulin

Time frame: 2 weeks of assigned intervention

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

Total Protein

Time frame: baseline

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

Total Protein

Time frame: 2 weeks of assigned intervention

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

Albumin/globulin ratio

Time frame: baseline

Albumin/globulin ratio measured as part of metabolic panel

Albumin/globulin ratio

Time frame: 2 weeks of assigned intervention

Albumin/globulin ratio measured as part of metabolic panel

Blood urea nitrogen/creatinine ratio

Time frame: baseline

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

Blood urea nitrogen/creatinine ratio

Time frame: 2 weeks of assigned intervention

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

Hematocrit

Time frame: baseline

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

Hematocrit

Time frame: 2 weeks of assigned intervention

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

Hemoglobin

Time frame: baseline

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

Hemoglobin

Time frame: 2 weeks of assigned intervention

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

Mean corpuscular volume

Time frame: baseline

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

Mean corpuscular volume

Time frame: 2 weeks of assigned intervention

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

Mean corpuscular hemoglobin

Time frame: baseline

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

Mean corpuscular hemoglobin

Time frame: 2 weeks of assigned intervention

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

Mean corpuscular hemoglobin concentration

Time frame: baseline

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

Mean corpuscular hemoglobin concentration

Time frame: 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

Time frame: baseline

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

Red cell distribution width

Time frame: 2 weeks of assigned intervention

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

Platelets

Time frame: baseline

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

Platelets

Time frame: 2 weeks of assigned intervention

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

Specific gravity

Time frame: baseline

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

Specific gravity

Time frame: 2 weeks of assigned intervention

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

pH

Time frame: baseline

pH as measured as part of urinalysis (no units)

pH

Time frame: 2 weeks of assigned intervention

pH as measured as part of urinalysis (no units)

Urine color

Time frame: baseline

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

Urine color

Time frame: 2 weeks of assigned intervention

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

Urine Appearance

Time frame: baseline

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

Urine Appearance

Time frame: 2 weeks of assigned intervention

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

White Blood Cell esterase

Time frame: baseline

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

White blood cell esterase

Time frame: 2 weeks of assigned intervention

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

Protein

Time frame: baseline

Protein as measured as part of urinalysis, if present

Protein

Time frame: 2 weeks of assigned intervention

Protein as measured as part of urinalysis, if present

Glucose

Time frame: baseline

Glucose as measured as part of urinalysis, if present

Glucose

Time frame: 2 weeks of assigned intervention

Glucose as measured as part of urinalysis, if present

Ketones

Time frame: baseline

Ketones as measured as part of urinalysis, if present

Ketones

Time frame: 2 weeks of assigned intervention

Ketones as measured as part of urinalysis, if present

Occult blood

Time frame: baseline

Occult blood as measured as part of urinalysis, if present

Occult blood

Time frame: 2 weeks of assigned intervention

Occult blood as measured as part of urinalysis, if present

Bilirubin

Time frame: baseline

Bilirubin as measured as part of urinalysis, if present

Bilirubin

Time frame: 2 weeks of assigned intervention

Bilirubin as measured as part of urinalysis, if present

Urobilinogen

Time frame: baseline

Urobilinogen as measured as part of urinalysis in milligrams per deciliter

Urobilinogen

Time frame: 2 weeks of assigned intervention

Urobilinogen as measured as part of urinalysis in milligrams per deciliter

Microscopic examination

Time frame: baseline

Microscopic examination as reported as part of urinalysis, if indicated

Microscopic examination

Time frame: 2 weeks of assigned intervention

Microscopic examination as reported as part of urinalysis, if indicated

Total Cholesterol

Time frame: baseline

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

Total Cholesterol

Time frame: 2 weeks of assigned intervention

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

Triglycerides

Time frame: baseline

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

Triglycerides

Time frame: 2 weeks of assigned intervention

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

High-Density Lipoprotein Cholesterol

Time frame: baseline

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

High-Density Lipoprotein Cholesterol

Time frame: 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

Time frame: baseline

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

Very Low-Density Lipoprotein Cholesterol

Time frame: 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

Time frame: baseline

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

Low-Density Lipoprotein Cholesterol

Time frame: 2 weeks of assigned intervention

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

Mood questionnaire

Time frame: 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)

Mood questionnaire

Time frame: 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

Time frame: 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.

36-item short form survey

Time frame: 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

Time frame: 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)

Tolerability Questionnaire

Time frame: 1 day 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)

Tolerability Questionnaire

Time frame: 3 days 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)

Tolerability Questionnaire

Time frame: 1 week 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)

Tolerability Questionnaire

Time frame: 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

Time frame: 3 days before baseline

Self-reported number and consistency of daily bowel movements

Bristol Chart

Time frame: 2 days before baseline

Self-reported number and consistency of daily bowel movements

Bristol Chart

Time frame: 1 day before baseline

Self-reported number and consistency of daily bowel movements

Bristol Chart

Time frame: 1 day of assigned treatment

Self-reported number and consistency of daily bowel movements

Bristol Chart

Time frame: 2 days on assigned treatment

Self-reported number and consistency of daily bowel movements

Bristol Chart

Time frame: 3 days of assigned treatment

Self-reported number and consistency of daily bowel movements

Bristol Chart

Time frame: 7 days of assigned treatment

Self-reported number and consistency of daily bowel movements

Bristol Chart

Time frame: 14 days of assigned treatment

Self-reported number and consistency of daily bowel movements

Weight

Time frame: baseline

Body weight measured in kg

Weight

Time frame: 2 weeks of assigned treatment

Body weight measured in kg

Skin age

Time frame: baseline

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

Skin age

Time frame: 2 weeks of assigned treatment

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

Diastolic blood pressure

Time frame: baseline

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

Diastolic blood pressure

Time frame: 2 weeks of assigned treatment

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

Systolic blood pressure

Time frame: baseline

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

Systolic blood pressure

Time frame: 2 weeks of assigned treatment

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

Heart rate

Time frame: baseline

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

Heart Rate

Time frame: 2 weeks of assigned treatment

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

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

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
  • 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

Where

  • Memphis, Tennessee

Collaborators

INNOSUPPS

Related conditions & keywords

ConstipationBloatingInno Cleanse

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Apr 2, 2026 · Source of record for eligibility and locations

📊
1 of 30 participants interested
3% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

Memphis

Tennessee

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

Find More Constipation Trials by City

Browse all constipation clinical trials in these cities — not just this study.

Browse More Trials by Condition

Looking for Constipation Treatment in Memphis?

Join others in Tennessee exploring innovative treatment options through clinical research

Constipation Treatment Options in Memphis, Tennessee

If you're searching for Constipation treatment in Memphis, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Memphis and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Constipation. All study-related care is provided at no cost to participants.

Local Sites
1 locations in Tennessee
Now Enrolling
Up to 30 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Constipation?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Constipation

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Constipation Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT07215351. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.