ConstipationNCT07215351
Impact of the Inno Cleanse Dietary Supplement on Gut Health and Associated Variables in Healthy Men and Women
A study testing Dietary supplement for digestive health in people with Constipation and Bloating, run by University of Memphis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Constipation, Bloating
- What is being tested?
- Dietary supplement for digestive health
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2025to 8 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- experience regular (2 or more days per week) bloating or constipation
- able to fast a minimum of 12 hours prior to testing visit
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Nutraceutical and Dietary Supplement Research
Memphis, Tennessee, 38152
About this study
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
- Constipation, Bloating
- Being tested
- Dietary supplement for digestive health, placebo capsule
- Keywords
- Inno Cleanse
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplement for digestive healthDietary 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.
placebo capsuleDietary supplement
Contains hydroxypropyl methylcellulose and cellulose
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alanine transaminase
Alanine transaminase measured as part of metabolic panel in international units per liter
Measured: baseline
Alanine transaminase
Alanine transaminase measured as part of metabolic panel in international units per liter
Measured: 2 weeks of assigned intervention
Aspartate transferase
Aspartate transferase measured as part of metabolic panel in international units per liter
Measured: baseline
Aspartate transferase
Aspartate transferase measured as part of metabolic panel in international units per liter
Measured: 2 weeks of assigned intervention
Albumin
Albumin measured as part of metabolic panel in grams per deciliter
Measured: baseline
Albumin
Albumin measured as part of metabolic panel in grams per deciliter
Measured: 2 weeks of assigned intervention
Alkaline phosphatase
Alkaline phosphatase measured as part of metabolic panel in international units per liter
Measured: baseline
Alkaline phosphatase
Alkaline phosphatase measured as part of metabolic panel in international units per liter
Measured: 2 weeks of assigned intervention
Total bilirubin
Total bilirubin measured as part of metabolic panel in milligrams per deciliter
Measured: baseline
Total Bilirubin
Total bilirubin measured as part of metabolic panel in milligrams per deciliter
Measured: 2 weeks of assigned intervention
Blood urea nitrogen
Blood urea nitrogen measured as part of metabolic panel in milligrams per deciliter
Measured: baseline
Blood urea nitrogen
Blood urea nitrogen measured as part of metabolic panel in milligrams per deciliter
Measured: 2 weeks of assigned intervention
Calcium
Calcium measured as part of metabolic panel in milligrams per deciliter
Measured: baseline
Calcium
Calcium measured as part of metabolic panel in milligrams per deciliter
Measured: 2 weeks of assigned intervention
Carbon dioxide
Carbon dioxide measured as part of metabolic panel in millimoles per liter
Measured: baseline
Carbon dioxide
Carbon dioxide measured as part of metabolic panel in millimoles per liter
Measured: 2 weeks of assigned intervention
Chloride
Chloride measured as part of metabolic panel in millimoles per liter.
Measured: baseline
Chloride
Chloride measured as part of metabolic panel in millimoles per liter.
Measured: 2 weeks of assigned intervention
Creatinine
Creatinine measured as part of metabolic panel in milligrams per deciliter
Measured: baseline
Creatinine
Creatinine measured as part of metabolic panel in milligrams per deciliter
Measured: 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
Measured: baseline
Estimated glomerular filtration rate
Estimated glomerular filtration rate as part of metabolic panel in milliliters per minute per 1.73
Measured: 2 weeks of assigned intervention
Blood Glucose
Glucose measured as part of metabolic panel in milligrams per deciliter
Measured: baseline
Blood Glucose
Glucose measured as part of metabolic panel in milligrams per deciliter
Measured: 2 weeks of assigned intervention
Potassium
Potassium measured as part of metabolic panel in millimoles per liter.
Measured: baseline
Potassium
Potassium measured as part of metabolic panel in millimoles per liter.
Measured: 2 weeks of assigned intervention
Sodium
Sodium measured as part of metabolic panel in millimoles per liter.
Measured: baseline
Sodium
Sodium measured as part of metabolic panel in millimoles per liter.
Measured: 2 weeks of assigned intervention
Total Globulin
Total Globulin measured as part of metabolic panel in grams per deciliter
Measured: baseline
Total Globulin
Total Globulin measured as part of metabolic panel in grams per deciliter
Measured: 2 weeks of assigned intervention
Total Protein
Total Protein measured as part of metabolic panel in grams per deciliter
Measured: baseline
Total Protein
Total Protein measured as part of metabolic panel in grams per deciliter
Measured: 2 weeks of assigned intervention
Albumin/globulin ratio
Albumin/globulin ratio measured as part of metabolic panel
Measured: baseline
Albumin/globulin ratio
Albumin/globulin ratio measured as part of metabolic panel
Measured: 2 weeks of assigned intervention
Blood urea nitrogen/creatinine ratio
Blood urea nitrogen/creatinine ratio measured as part of metabolic panel
Measured: baseline
Blood urea nitrogen/creatinine ratio
Blood urea nitrogen/creatinine ratio measured as part of metabolic panel
Measured: 2 weeks of assigned intervention
Hematocrit
Hematocrit as part of a complete blood count panel measured as percentage
Measured: baseline
Hematocrit
Hematocrit as part of a complete blood count panel measured as percentage
Measured: 2 weeks of assigned intervention
Hemoglobin
Hemoglobin as part of a complete blood count panel measured in grams per deciliter
Measured: baseline
Hemoglobin
Hemoglobin as part of a complete blood count panel measured in grams per deciliter
Measured: 2 weeks of assigned intervention
Mean corpuscular volume
Mean corpuscular volume as part of a complete blood count panel measured in femtoliters
Measured: baseline
Mean corpuscular volume
Mean corpuscular volume as part of a complete blood count panel measured in femtoliters
Measured: 2 weeks of assigned intervention
Mean corpuscular hemoglobin
Mean corpuscular hemoglobin as part of a complete blood count panel measured in picograms
Measured: baseline
Mean corpuscular hemoglobin
Mean corpuscular hemoglobin as part of a complete blood count panel measured in picograms
Measured: 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
Measured: baseline
Mean corpuscular hemoglobin concentration
Mean corpuscular hemoglobin concentration as part of a complete blood count panel measured in grams per deciliter
Measured: 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
Measured: baseline
Red cell distribution width
Red cell distribution width as part of a complete blood count panel measured as a percentage
Measured: 2 weeks of assigned intervention
Platelets
Platelets as part of a complete blood count panel measured as a count per 1000 per microliter
Measured: baseline
Platelets
Platelets as part of a complete blood count panel measured as a count per 1000 per microliter
Measured: 2 weeks of assigned intervention
Specific gravity
Specific gravity as measured as part of urinalysis (no units)
Measured: baseline
Specific gravity
Specific gravity as measured as part of urinalysis (no units)
Measured: 2 weeks of assigned intervention
pH
pH as measured as part of urinalysis (no units)
Measured: baseline
pH
pH as measured as part of urinalysis (no units)
Measured: 2 weeks of assigned intervention
Urine color
Urine color as reported as part of urinalysis (no units)
Measured: baseline
Urine color
Urine color as reported as part of urinalysis (no units)
Measured: 2 weeks of assigned intervention
Urine Appearance
Urine Appearance as reported as part of urinalysis (no units)
Measured: baseline
Urine Appearance
Urine Appearance as reported as part of urinalysis (no units)
Measured: 2 weeks of assigned intervention
White Blood Cell esterase
White blood cell esterase as measured as part of urinalysis, if present
Measured: baseline
White blood cell esterase
White blood cell esterase as measured as part of urinalysis, if present
Measured: 2 weeks of assigned intervention
Protein
Protein as measured as part of urinalysis, if present
Measured: baseline
Protein
Protein as measured as part of urinalysis, if present
Measured: 2 weeks of assigned intervention
Glucose
Glucose as measured as part of urinalysis, if present
Measured: baseline
Glucose
Glucose as measured as part of urinalysis, if present
Measured: 2 weeks of assigned intervention
Ketones
Ketones as measured as part of urinalysis, if present
Measured: baseline
Ketones
Ketones as measured as part of urinalysis, if present
Measured: 2 weeks of assigned intervention
Occult blood
Occult blood as measured as part of urinalysis, if present
Measured: baseline
Occult blood
Occult blood as measured as part of urinalysis, if present
Measured: 2 weeks of assigned intervention
Bilirubin
Bilirubin as measured as part of urinalysis, if present
Measured: baseline
Bilirubin
Bilirubin as measured as part of urinalysis, if present
Measured: 2 weeks of assigned intervention
Urobilinogen
Urobilinogen as measured as part of urinalysis in milligrams per deciliter
Measured: baseline
Urobilinogen
Urobilinogen as measured as part of urinalysis in milligrams per deciliter
Measured: 2 weeks of assigned intervention
Microscopic examination
Microscopic examination as reported as part of urinalysis, if indicated
Measured: baseline
Microscopic examination
Microscopic examination as reported as part of urinalysis, if indicated
Measured: 2 weeks of assigned intervention
Total Cholesterol
Total Cholesterol as reported as part of lipid panel in milligrams per deciliter
Measured: baseline
Total Cholesterol
Total Cholesterol as reported as part of lipid panel in milligrams per deciliter
Measured: 2 weeks of assigned intervention
Triglycerides
Triglycerides as reported as part of lipid panel in milligrams per deciliter
Measured: baseline
Triglycerides
Triglycerides as reported as part of lipid panel in milligrams per deciliter
Measured: 2 weeks of assigned intervention
High-Density Lipoprotein Cholesterol
High-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter
Measured: baseline
High-Density Lipoprotein Cholesterol
High-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter
Measured: 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
Measured: baseline
Very Low-Density Lipoprotein Cholesterol
Very Low-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter
Measured: 2 weeks of assigned intervention
Low-Density Lipoprotein Cholesterol
Low-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter
Measured: baseline
Low-Density Lipoprotein Cholesterol
Low-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 2 weeks of assigned treatment
Bristol Chart
Self-reported number and consistency of daily bowel movements
Measured: 3 days before baseline
Bristol Chart
Self-reported number and consistency of daily bowel movements
Measured: 2 days before baseline
Bristol Chart
Self-reported number and consistency of daily bowel movements
Measured: 1 day before baseline
Bristol Chart
Self-reported number and consistency of daily bowel movements
Measured: 1 day of assigned treatment
Bristol Chart
Self-reported number and consistency of daily bowel movements
Measured: 2 days on assigned treatment
Bristol Chart
Self-reported number and consistency of daily bowel movements
Measured: 3 days of assigned treatment
Bristol Chart
Self-reported number and consistency of daily bowel movements
Measured: 7 days of assigned treatment
Bristol Chart
Self-reported number and consistency of daily bowel movements
Measured: 14 days of assigned treatment
Weight
Body weight measured in kg
Measured: baseline
Weight
Body weight measured in kg
Measured: 2 weeks of assigned treatment
Skin age
a quantitative skin age based on skin parameters will be determined by the 3D P Plus system
Measured: baseline
Skin age
a quantitative skin age based on skin parameters will be determined by the 3D P Plus system
Measured: 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
Measured: baseline
Diastolic blood pressure
Diastolic blood pressure will be measured using an automated blood pressure machine in units millimeters of mercury
Measured: 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
Measured: baseline
Systolic blood pressure
Systolic blood pressure will be measured using an automated blood pressure machine in units millimeters of mercury
Measured: 2 weeks of assigned treatment
Heart rate
Heart rate will be measured using an automated blood pressure machine in units beats per minute
Measured: baseline
Heart Rate
Hear rate will be measured using an automated blood pressure machine in units beats per minute
Measured: 2 weeks of assigned treatment
Secondary outcomes (6)
Daily food diary
Daily food diary of all food and drink consumed that day
Measured: 3 days prior to baseline visit
Daily food diary
Daily food diary of all food and drink consumed that day
Measured: 2 days prior to baseline visit
Daily food diary
Daily food diary of all food and drink consumed that day
Measured: 1 day prior to baseline visit
Daily food diary
Daily food diary of all food and drink consumed that day
Measured: 3 days prior to 2 week visit
Daily food diary
Daily food diary of all food and drink consumed that day
Measured: 2 days prior to 2 week visit
Daily food diary
Daily food diary of all food and drink consumed that day
Measured: 1 day prior to 2 week visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2025
- Study start7 Oct 2025
- Primary completion2 Jun 2026
- Study completion8 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Memphis
- Sponsor type
- University, hospital or other
- Collaborators
- INNOSUPPS
- Responsible party
- Principal investigator, Richard Bloomer, University of Memphis
- Investigators
- Richard Bloomer, PhD, Principal investigator, University of Memphis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07215351
- Sponsor's protocol ID
- PRO-FY2025-554
- Status last verified
- Aug 2026
- First submitted
- 8 Oct 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Inno Cleanse Dietary Supplement on Gut Health and Associated Variables in Healthy Men and Women
- ClinicalTrials.gov ID
- NCT07215351
- Acronym / sponsor ID
- PRO-FY2025-554
- Conditions
- Constipation, Bloating
- Keywords
- Inno Cleanse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MemphisUniversity, hospital or other
- Collaborators
- INNOSUPPS
- Study start
- 7 Oct 2025 (actual)
- Primary completion
- 2 Jun 2026 (actual)
- Study completion
- 8 Jul 2026 (actual)
- First posted
- 10 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Dietary Supplement | Experimental | Dietary Supplement: Dietary supplement for digestive health15 randomly assigned individuals will receive 2 capsules daily of the experimental dietary supplement for 2 weeks with assessments prior and after intervention. |
| Placebo Control | Placebo comparator | Dietary Supplement: placebo capsule15 randomly assigned individuals will receive 2 capsules daily of the placebo for 2 weeks with assessments prior and after intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- experience regular (2 or more days per week) bloating or constipation
- able to fast a minimum of 12 hours prior to testing visit
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary supplement for digestive healthDietary 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 | Experimental Dietary Supplement |
| placebo capsuleContains hydroxypropyl methylcellulose and cellulose | Dietary supplement | Placebo Control |
Primary outcome
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
6 secondary outcomes
Daily food diary
Time frame: 3 days prior to baseline visit
Daily food diary
Time frame: 2 days prior to baseline visit
Daily food diary
Time frame: 1 day prior to baseline visit
Daily food diary
Time frame: 3 days prior to 2 week visit
Daily food diary
Time frame: 2 days prior to 2 week visit
Daily food diary
Time frame: 1 day prior to 2 week visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Bloomer, PhD principal investigator
University of Memphis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary supplement for digestive health in people with Constipation and Bloating, run by University of Memphis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alanine transaminase (time frame: baseline). The study lists 111 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.