Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT07215351
Status:
RECRUITING
Last Update Posted:
2025-10-14
First Post:
2025-10-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of the Inno Cleanse Dietary Supplement on Gut Health and Associated Variables in Healthy Men and Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019587', 'term': 'Dietary Supplements'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-09', 'studyFirstSubmitDate': '2025-10-08', 'studyFirstSubmitQcDate': '2025-10-08', 'lastUpdatePostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alanine transaminase', 'timeFrame': 'baseline', 'description': 'Alanine transaminase measured as part of metabolic panel in international units per liter'}, {'measure': 'Alanine transaminase', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Alanine transaminase measured as part of metabolic panel in international units per liter'}, {'measure': 'Aspartate transferase', 'timeFrame': 'baseline', 'description': 'Aspartate transferase measured as part of metabolic panel in international units per liter'}, {'measure': 'Aspartate transferase', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Aspartate transferase measured as part of metabolic panel in international units per liter'}, {'measure': 'Albumin', 'timeFrame': 'baseline', 'description': 'Albumin measured as part of metabolic panel in grams per deciliter'}, {'measure': 'Albumin', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Albumin measured as part of metabolic panel in grams per deciliter'}, {'measure': 'Alkaline phosphatase', 'timeFrame': 'baseline', 'description': 'Alkaline phosphatase measured as part of metabolic panel in international units per liter'}, {'measure': 'Alkaline phosphatase', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Alkaline phosphatase measured as part of metabolic panel in international units per liter'}, {'measure': 'Total bilirubin', 'timeFrame': 'baseline', 'description': 'Total bilirubin measured as part of metabolic panel in milligrams per deciliter'}, {'measure': 'Total Bilirubin', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Total bilirubin measured as part of metabolic panel in milligrams per deciliter'}, {'measure': 'Blood urea nitrogen', 'timeFrame': 'baseline', 'description': 'Blood urea nitrogen measured as part of metabolic panel in milligrams per deciliter'}, {'measure': 'Blood urea nitrogen', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Blood urea nitrogen measured as part of metabolic panel in milligrams per deciliter'}, {'measure': 'Calcium', 'timeFrame': 'baseline', 'description': 'Calcium measured as part of metabolic panel in milligrams per deciliter'}, {'measure': 'Calcium', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Calcium measured as part of metabolic panel in milligrams per deciliter'}, {'measure': 'Carbon dioxide', 'timeFrame': 'baseline', 'description': 'Carbon dioxide measured as part of metabolic panel in millimoles per liter'}, {'measure': 'Carbon dioxide', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Carbon dioxide measured as part of metabolic panel in millimoles per liter'}, {'measure': 'Chloride', 'timeFrame': 'baseline', 'description': 'Chloride measured as part of metabolic panel in millimoles per liter.'}, {'measure': 'Chloride', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Chloride measured as part of metabolic panel in millimoles per liter.'}, {'measure': 'Creatinine', 'timeFrame': 'baseline', 'description': 'Creatinine measured as part of metabolic panel in milligrams per deciliter'}, {'measure': 'Creatinine', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Creatinine measured as part of metabolic panel in milligrams per deciliter'}, {'measure': 'Estimated glomerular filtration rate', 'timeFrame': 'baseline', 'description': 'Estimated glomerular filtration rate as part of metabolic panel in milliliters per minute per 1.73'}, {'measure': 'Estimated glomerular filtration rate', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Estimated glomerular filtration rate as part of metabolic panel in milliliters per minute per 1.73'}, {'measure': 'Blood Glucose', 'timeFrame': 'baseline', 'description': 'Glucose measured as part of metabolic panel in milligrams per deciliter'}, {'measure': 'Blood Glucose', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Glucose measured as part of metabolic panel in milligrams per deciliter'}, {'measure': 'Potassium', 'timeFrame': 'baseline', 'description': 'Potassium measured as part of metabolic panel in millimoles per liter.'}, {'measure': 'Potassium', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Potassium measured as part of metabolic panel in millimoles per liter.'}, {'measure': 'Sodium', 'timeFrame': 'baseline', 'description': 'Sodium measured as part of metabolic panel in millimoles per liter.'}, {'measure': 'Sodium', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Sodium measured as part of metabolic panel in millimoles per liter.'}, {'measure': 'Total Globulin', 'timeFrame': 'baseline', 'description': 'Total Globulin measured as part of metabolic panel in grams per deciliter'}, {'measure': 'Total Globulin', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Total Globulin measured as part of metabolic panel in grams per deciliter'}, {'measure': 'Total Protein', 'timeFrame': 'baseline', 'description': 'Total Protein measured as part of metabolic panel in grams per deciliter'}, {'measure': 'Total Protein', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Total Protein measured as part of metabolic panel in grams per deciliter'}, {'measure': 'Albumin/globulin ratio', 'timeFrame': 'baseline', 'description': 'Albumin/globulin ratio measured as part of metabolic panel'}, {'measure': 'Albumin/globulin ratio', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Albumin/globulin ratio measured as part of metabolic panel'}, {'measure': 'Blood urea nitrogen/creatinine ratio', 'timeFrame': 'baseline', 'description': 'Blood urea nitrogen/creatinine ratio measured as part of metabolic panel'}, {'measure': 'Blood urea nitrogen/creatinine ratio', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Blood urea nitrogen/creatinine ratio measured as part of metabolic panel'}, {'measure': 'Hematocrit', 'timeFrame': 'baseline', 'description': 'Hematocrit as part of a complete blood count panel measured as percentage'}, {'measure': 'Hematocrit', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Hematocrit as part of a complete blood count panel measured as percentage'}, {'measure': 'Hemoglobin', 'timeFrame': 'baseline', 'description': 'Hemoglobin as part of a complete blood count panel measured in grams per deciliter'}, {'measure': 'Hemoglobin', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Hemoglobin as part of a complete blood count panel measured in grams per deciliter'}, {'measure': 'Mean corpuscular volume', 'timeFrame': 'baseline', 'description': 'Mean corpuscular volume as part of a complete blood count panel measured in femtoliters'}, {'measure': 'Mean corpuscular volume', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Mean corpuscular volume as part of a complete blood count panel measured in femtoliters'}, {'measure': 'Mean corpuscular hemoglobin', 'timeFrame': 'baseline', 'description': 'Mean corpuscular hemoglobin as part of a complete blood count panel measured in picograms'}, {'measure': 'Mean corpuscular hemoglobin', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Mean corpuscular hemoglobin as part of a complete blood count panel measured in picograms'}, {'measure': 'Mean corpuscular hemoglobin concentration', 'timeFrame': 'baseline', 'description': 'Mean corpuscular hemoglobin concentration as part of a complete blood count panel measured in grams per deciliter'}, {'measure': 'Mean corpuscular hemoglobin concentration', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Mean corpuscular hemoglobin concentration as part of a complete blood count panel measured in grams per deciliter'}, {'measure': 'Red cell distribution width', 'timeFrame': 'baseline', 'description': 'Red cell distribution width as part of a complete blood count panel measured as a percentage'}, {'measure': 'Red cell distribution width', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Red cell distribution width as part of a complete blood count panel measured as a percentage'}, {'measure': 'Platelets', 'timeFrame': 'baseline', 'description': 'Platelets as part of a complete blood count panel measured as a count per 1000 per microliter'}, {'measure': 'Platelets', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Platelets as part of a complete blood count panel measured as a count per 1000 per microliter'}, {'measure': 'Specific gravity', 'timeFrame': 'baseline', 'description': 'Specific gravity as measured as part of urinalysis (no units)'}, {'measure': 'Specific gravity', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Specific gravity as measured as part of urinalysis (no units)'}, {'measure': 'pH', 'timeFrame': 'baseline', 'description': 'pH as measured as part of urinalysis (no units)'}, {'measure': 'pH', 'timeFrame': '2 weeks of assigned intervention', 'description': 'pH as measured as part of urinalysis (no units)'}, {'measure': 'Urine color', 'timeFrame': 'baseline', 'description': 'Urine color as reported as part of urinalysis (no units)'}, {'measure': 'Urine color', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Urine color as reported as part of urinalysis (no units)'}, {'measure': 'Urine Appearance', 'timeFrame': 'baseline', 'description': 'Urine Appearance as reported as part of urinalysis (no units)'}, {'measure': 'Urine Appearance', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Urine Appearance as reported as part of urinalysis (no units)'}, {'measure': 'White Blood Cell esterase', 'timeFrame': 'baseline', 'description': 'White blood cell esterase as measured as part of urinalysis, if present'}, {'measure': 'White blood cell esterase', 'timeFrame': '2 weeks of assigned intervention', 'description': 'White blood cell esterase as measured as part of urinalysis, if present'}, {'measure': 'Protein', 'timeFrame': 'baseline', 'description': 'Protein as measured as part of urinalysis, if present'}, {'measure': 'Protein', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Protein as measured as part of urinalysis, if present'}, {'measure': 'Glucose', 'timeFrame': 'baseline', 'description': 'Glucose as measured as part of urinalysis, if present'}, {'measure': 'Glucose', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Glucose as measured as part of urinalysis, if present'}, {'measure': 'Ketones', 'timeFrame': 'baseline', 'description': 'Ketones as measured as part of urinalysis, if present'}, {'measure': 'Ketones', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Ketones as measured as part of urinalysis, if present'}, {'measure': 'Occult blood', 'timeFrame': 'baseline', 'description': 'Occult blood as measured as part of urinalysis, if present'}, {'measure': 'Occult blood', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Occult blood as measured as part of urinalysis, if present'}, {'measure': 'Bilirubin', 'timeFrame': 'baseline', 'description': 'Bilirubin as measured as part of urinalysis, if present'}, {'measure': 'Bilirubin', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Bilirubin as measured as part of urinalysis, if present'}, {'measure': 'Urobilinogen', 'timeFrame': 'baseline', 'description': 'Urobilinogen as measured as part of urinalysis in milligrams per deciliter'}, {'measure': 'Urobilinogen', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Urobilinogen as measured as part of urinalysis in milligrams per deciliter'}, {'measure': 'Microscopic examination', 'timeFrame': 'baseline', 'description': 'Microscopic examination as reported as part of urinalysis, if indicated'}, {'measure': 'Microscopic examination', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Microscopic examination as reported as part of urinalysis, if indicated'}, {'measure': 'Total Cholesterol', 'timeFrame': 'baseline', 'description': 'Total Cholesterol as reported as part of lipid panel in milligrams per deciliter'}, {'measure': 'Total Cholesterol', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Total Cholesterol as reported as part of lipid panel in milligrams per deciliter'}, {'measure': 'Triglycerides', 'timeFrame': 'baseline', 'description': 'Triglycerides as reported as part of lipid panel in milligrams per deciliter'}, {'measure': 'Triglycerides', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Triglycerides as reported as part of lipid panel in milligrams per deciliter'}, {'measure': 'High-Density Lipoprotein Cholesterol', 'timeFrame': 'baseline', 'description': 'High-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter'}, {'measure': 'High-Density Lipoprotein Cholesterol', 'timeFrame': '2 weeks of assigned intervention', 'description': 'High-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter'}, {'measure': 'Very Low-Density Lipoprotein Cholesterol', 'timeFrame': 'baseline', 'description': 'Very Low-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter'}, {'measure': 'Very Low-Density Lipoprotein Cholesterol', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Very Low-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter'}, {'measure': 'Low-Density Lipoprotein Cholesterol', 'timeFrame': 'baseline', 'description': 'Low-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter'}, {'measure': 'Low-Density Lipoprotein Cholesterol', 'timeFrame': '2 weeks of assigned intervention', 'description': 'Low-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter'}, {'measure': 'Mood questionnaire', 'timeFrame': 'baseline', 'description': '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)'}, {'measure': 'Mood questionnaire', 'timeFrame': '2 weeks of assigned intervention', 'description': '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)'}, {'measure': '36-item short form survey', 'timeFrame': 'baseline', 'description': '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.'}, {'measure': '36-item short form survey', 'timeFrame': '2 weeks of assigned intervention', 'description': '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.'}, {'measure': 'Tolerability Questionnaire', 'timeFrame': 'baseline', 'description': '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)'}, {'measure': 'Tolerability Questionnaire', 'timeFrame': '1 day of assigned treatment', 'description': '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)'}, {'measure': 'Tolerability Questionnaire', 'timeFrame': '3 days of assigned treatment', 'description': '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)'}, {'measure': 'Tolerability Questionnaire', 'timeFrame': '1 week of assigned treatment', 'description': '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)'}, {'measure': 'Tolerability Questionnaire', 'timeFrame': '2 weeks of assigned treatment', 'description': '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)'}, {'measure': 'Bristol Chart', 'timeFrame': '3 days before baseline', 'description': 'Self-reported number and consistency of daily bowel movements'}, {'measure': 'Bristol Chart', 'timeFrame': '2 days before baseline', 'description': 'Self-reported number and consistency of daily bowel movements'}, {'measure': 'Bristol Chart', 'timeFrame': '1 day before baseline', 'description': 'Self-reported number and consistency of daily bowel movements'}, {'measure': 'Bristol Chart', 'timeFrame': '1 day of assigned treatment', 'description': 'Self-reported number and consistency of daily bowel movements'}, {'measure': 'Bristol Chart', 'timeFrame': '2 days on assigned treatment', 'description': 'Self-reported number and consistency of daily bowel movements'}, {'measure': 'Bristol Chart', 'timeFrame': '3 days of assigned treatment', 'description': 'Self-reported number and consistency of daily bowel movements'}, {'measure': 'Bristol Chart', 'timeFrame': '7 days of assigned treatment', 'description': 'Self-reported number and consistency of daily bowel movements'}, {'measure': 'Bristol Chart', 'timeFrame': '14 days of assigned treatment', 'description': 'Self-reported number and consistency of daily bowel movements'}, {'measure': 'Weight', 'timeFrame': 'baseline', 'description': 'Body weight measured in kg'}, {'measure': 'Weight', 'timeFrame': '2 weeks of assigned treatment', 'description': 'Body weight measured in kg'}, {'measure': 'Skin age', 'timeFrame': 'baseline', 'description': 'a quantitative skin age based on skin parameters will be determined by the 3D P Plus system'}, {'measure': 'Skin age', 'timeFrame': '2 weeks of assigned treatment', 'description': 'a quantitative skin age based on skin parameters will be determined by the 3D P Plus system'}, {'measure': 'Diastolic blood pressure', 'timeFrame': 'baseline', 'description': 'Diastolic blood pressure will be measured using an automated blood pressure machine in units millimeters of mercury'}, {'measure': 'Diastolic blood pressure', 'timeFrame': '2 weeks of assigned treatment', 'description': 'Diastolic blood pressure will be measured using an automated blood pressure machine in units millimeters of mercury'}, {'measure': 'Systolic blood pressure', 'timeFrame': 'baseline', 'description': 'Systolic blood pressure will be measured using an automated blood pressure machine in units millimeters of mercury'}, {'measure': 'Systolic blood pressure', 'timeFrame': '2 weeks of assigned treatment', 'description': 'Systolic blood pressure will be measured using an automated blood pressure machine in units millimeters of mercury'}, {'measure': 'Heart rate', 'timeFrame': 'baseline', 'description': 'Heart rate will be measured using an automated blood pressure machine in units beats per minute'}, {'measure': 'Heart Rate', 'timeFrame': '2 weeks of assigned treatment', 'description': 'Hear rate will be measured using an automated blood pressure machine in units beats per minute'}], 'secondaryOutcomes': [{'measure': 'Daily food diary', 'timeFrame': '3 days prior to baseline visit', 'description': 'Daily food diary of all food and drink consumed that day'}, {'measure': 'Daily food diary', 'timeFrame': '2 days prior to baseline visit', 'description': 'Daily food diary of all food and drink consumed that day'}, {'measure': 'Daily food diary', 'timeFrame': '1 day prior to baseline visit', 'description': 'Daily food diary of all food and drink consumed that day'}, {'measure': 'Daily food diary', 'timeFrame': '3 days prior to 2 week visit', 'description': 'Daily food diary of all food and drink consumed that day'}, {'measure': 'Daily food diary', 'timeFrame': '2 days prior to 2 week visit', 'description': 'Daily food diary of all food and drink consumed that day'}, {'measure': 'Daily food diary', 'timeFrame': '1 day prior to 2 week visit', 'description': 'Daily food diary of all food and drink consumed that day'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Inno Cleanse'], 'conditions': ['Constipation', 'Bloating']}, 'descriptionModule': {'briefSummary': "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.\n\nDespite 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.\n\nTherefore, 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* experience regular (2 or more days per week) bloating or constipation\n* able to fast a minimum of 12 hours prior to testing visit\n\nExclusion Criteria:\n\n* pregnant, planning to become pregnant, or breastfeeding\n* 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).\n* experienced a severe allergic reaction that resulted in emergency care\n* 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.\n* experiencing regular diarrhea\n* active infection or illness\n* diabetic\n* hypertensive\n* cardiovascular disease\n* breast, uterine, or ovarian cancer\n* uterine fibroids or endometriosis\n* taking medications or supplements that may alter gut health including but not limited to diuretics, laxatives, anti-diarrheal, anticholinergic agents, or antispasmodic agents.\n* previous adverse experience with laxatives\n* 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.\n* tobacco user\n* strenuous activity within 24 hours of testing visits\n* caffeine within 24 hours of testing visit\n* alcohol within 24 hours of testing visit"}, 'identificationModule': {'nctId': 'NCT07215351', 'briefTitle': 'Impact of the Inno Cleanse Dietary Supplement on Gut Health and Associated Variables in Healthy Men and Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Memphis'}, 'officialTitle': 'Impact of the Inno Cleanse Dietary Supplement on Gut Health and Associated Variables in Healthy Men and Women', 'orgStudyIdInfo': {'id': 'PRO-FY2025-554'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Dietary Supplement', 'description': '15 randomly assigned individuals will receive 2 capsules daily of the experimental dietary supplement for 2 weeks with assessments prior and after intervention.', 'interventionNames': ['Dietary Supplement: Dietary supplement for digestive health']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Control', 'description': '15 randomly assigned individuals will receive 2 capsules daily of the placebo for 2 weeks with assessments prior and after intervention.', 'interventionNames': ['Dietary Supplement: placebo capsule']}], 'interventions': [{'name': 'Dietary supplement for digestive health', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['Experimental Dietary Supplement']}, {'name': 'placebo capsule', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Contains hydroxypropyl methylcellulose and cellulose', 'armGroupLabels': ['Placebo Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38152', 'city': 'Memphis', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jacquelyn Pence, PhD', 'role': 'CONTACT', 'email': 'jpence1@memphis.edu', 'phone': '901-678-1547'}], 'facility': 'Center for Nutraceutical and Dietary Supplement Research', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'centralContacts': [{'name': 'Jacquelyn Pence, PhD', 'role': 'CONTACT', 'email': 'jpence1@memphis.edu', 'phone': '901-678-1547'}], 'overallOfficials': [{'name': 'Richard Bloomer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Memphis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Memphis', 'class': 'OTHER'}, 'collaborators': [{'name': 'INNOSUPPS', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dean of College of Health Sciences', 'investigatorFullName': 'Richard Bloomer', 'investigatorAffiliation': 'University of Memphis'}}}}