Impact of the Inno Cleanse Dietary Supplement on Gut Health and Associated Variables in Healthy Men and Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Mean corpuscular hemoglobin
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •experience regular (2 or more days per week) bloating or constipation
- •able to fast a minimum of 12 hours prior to testing visit
排除标准
- •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
研究组 & 干预措施
Experimental Dietary Supplement
15 randomly assigned individuals will receive 2 capsules daily of the experimental dietary supplement for 2 weeks with assessments prior and after intervention.
干预措施: Dietary supplement for digestive health (Dietary Supplement)
Placebo Control
15 randomly assigned individuals will receive 2 capsules daily of the placebo for 2 weeks with assessments prior and after intervention.
干预措施: placebo capsule (Dietary Supplement)
结局指标
主要结局
Mean corpuscular hemoglobin
时间窗: 2 weeks of assigned intervention
Mean corpuscular hemoglobin as part of a complete blood count panel measured in picograms
Mean corpuscular hemoglobin concentration
时间窗: 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
时间窗: 2 weeks of assigned intervention
Red cell distribution width as part of a complete blood count panel measured as a percentage
Platelets
时间窗: 2 weeks of assigned intervention
Platelets as part of a complete blood count panel measured as a count per 1000 per microliter
Specific gravity
时间窗: 2 weeks of assigned intervention
Specific gravity as measured as part of urinalysis (no units)
pH
时间窗: 2 weeks of assigned intervention
pH as measured as part of urinalysis (no units)
Urine color
时间窗: 2 weeks of assigned intervention
Urine color as reported as part of urinalysis (no units)
Urine Appearance
时间窗: 2 weeks of assigned intervention
Urine Appearance as reported as part of urinalysis (no units)
White Blood Cell esterase
时间窗: baseline
White blood cell esterase as measured as part of urinalysis, if present
White blood cell esterase
时间窗: 2 weeks of assigned intervention
White blood cell esterase as measured as part of urinalysis, if present
Protein
时间窗: 2 weeks of assigned intervention
Protein as measured as part of urinalysis, if present
Glucose
时间窗: 2 weeks of assigned intervention
Glucose as measured as part of urinalysis, if present
Ketones
时间窗: 2 weeks of assigned intervention
Ketones as measured as part of urinalysis, if present
Occult blood
时间窗: 2 weeks of assigned intervention
Occult blood as measured as part of urinalysis, if present
Bilirubin
时间窗: 2 weeks of assigned intervention
Bilirubin as measured as part of urinalysis, if present
Urobilinogen
时间窗: 2 weeks of assigned intervention
Urobilinogen as measured as part of urinalysis in milligrams per deciliter
Microscopic examination
时间窗: 2 weeks of assigned intervention
Microscopic examination as reported as part of urinalysis, if indicated
Total Cholesterol
时间窗: 2 weeks of assigned intervention
Total Cholesterol as reported as part of lipid panel in milligrams per deciliter
Triglycerides
时间窗: 2 weeks of assigned intervention
Triglycerides as reported as part of lipid panel in milligrams per deciliter
High-Density Lipoprotein Cholesterol
时间窗: 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
时间窗: 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
时间窗: 2 weeks of assigned intervention
Low-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter
Calcium
时间窗: 2 weeks of assigned intervention
Calcium measured as part of metabolic panel in milligrams per deciliter
Carbon dioxide
时间窗: 2 weeks of assigned intervention
Carbon dioxide measured as part of metabolic panel in millimoles per liter
Chloride
时间窗: 2 weeks of assigned intervention
Chloride measured as part of metabolic panel in millimoles per liter.
Creatinine
时间窗: 2 weeks of assigned intervention
Creatinine measured as part of metabolic panel in milligrams per deciliter
Estimated glomerular filtration rate
时间窗: 2 weeks of assigned intervention
Estimated glomerular filtration rate as part of metabolic panel in milliliters per minute per 1.73
Blood Glucose
时间窗: 2 weeks of assigned intervention
Glucose measured as part of metabolic panel in milligrams per deciliter
Potassium
时间窗: 2 weeks of assigned intervention
Potassium measured as part of metabolic panel in millimoles per liter.
Sodium
时间窗: 2 weeks of assigned intervention
Sodium measured as part of metabolic panel in millimoles per liter.
Total Globulin
时间窗: 2 weeks of assigned intervention
Total Globulin measured as part of metabolic panel in grams per deciliter
Total Protein
时间窗: 2 weeks of assigned intervention
Total Protein measured as part of metabolic panel in grams per deciliter
Albumin/globulin ratio
时间窗: 2 weeks of assigned intervention
Albumin/globulin ratio measured as part of metabolic panel
Blood urea nitrogen/creatinine ratio
时间窗: 2 weeks of assigned intervention
Blood urea nitrogen/creatinine ratio measured as part of metabolic panel
Hematocrit
时间窗: 2 weeks of assigned intervention
Hematocrit as part of a complete blood count panel measured as percentage
Hemoglobin
时间窗: 2 weeks of assigned intervention
Hemoglobin as part of a complete blood count panel measured in grams per deciliter
Mean corpuscular volume
时间窗: 2 weeks of assigned intervention
Mean corpuscular volume as part of a complete blood count panel measured in femtoliters
Blood urea nitrogen
时间窗: 2 weeks of assigned intervention
Blood urea nitrogen measured as part of metabolic panel in milligrams per deciliter
Alanine transaminase
时间窗: 2 weeks of assigned intervention
Alanine transaminase measured as part of metabolic panel in international units per liter
Aspartate transferase
时间窗: 2 weeks of assigned intervention
Aspartate transferase measured as part of metabolic panel in international units per liter
Albumin
时间窗: 2 weeks of assigned intervention
Albumin measured as part of metabolic panel in grams per deciliter
Alkaline phosphatase
时间窗: 2 weeks of assigned intervention
Alkaline phosphatase measured as part of metabolic panel in international units per liter
Total bilirubin
时间窗: baseline
Total bilirubin measured as part of metabolic panel in milligrams per deciliter
Total Bilirubin
时间窗: 2 weeks of assigned intervention
Total bilirubin measured as part of metabolic panel in milligrams per deciliter
Mood questionnaire
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 14 days of assigned treatment
Self-reported number and consistency of daily bowel movements
Weight
时间窗: 2 weeks of assigned treatment
Body weight measured in kg
Skin age
时间窗: 2 weeks of assigned treatment
a quantitative skin age based on skin parameters will be determined by the 3D P Plus system
Alanine transaminase
时间窗: 2 weeks of assigned intervention
Alanine transaminase measured as part of metabolic panel in international units per liter
Aspartate transferase
时间窗: 2 weeks of assigned intervention
Aspartate transferase measured as part of metabolic panel in international units per liter
Albumin
时间窗: 2 weeks of assigned intervention
Albumin measured as part of metabolic panel in grams per deciliter
Alkaline phosphatase
时间窗: 2 weeks of assigned intervention
Alkaline phosphatase measured as part of metabolic panel in international units per liter
Total bilirubin
时间窗: baseline
Total bilirubin measured as part of metabolic panel in milligrams per deciliter
Total Bilirubin
时间窗: 2 weeks of assigned intervention
Total bilirubin measured as part of metabolic panel in milligrams per deciliter
Blood urea nitrogen
时间窗: 2 weeks of assigned intervention
Blood urea nitrogen measured as part of metabolic panel in milligrams per deciliter
Calcium
时间窗: 2 weeks of assigned intervention
Calcium measured as part of metabolic panel in milligrams per deciliter
Carbon dioxide
时间窗: 2 weeks of assigned intervention
Carbon dioxide measured as part of metabolic panel in millimoles per liter
Chloride
时间窗: 2 weeks of assigned intervention
Chloride measured as part of metabolic panel in millimoles per liter.
Creatinine
时间窗: 2 weeks of assigned intervention
Creatinine measured as part of metabolic panel in milligrams per deciliter
Estimated glomerular filtration rate
时间窗: 2 weeks of assigned intervention
Estimated glomerular filtration rate as part of metabolic panel in milliliters per minute per 1.73
Blood Glucose
时间窗: 2 weeks of assigned intervention
Glucose measured as part of metabolic panel in milligrams per deciliter
Potassium
时间窗: 2 weeks of assigned intervention
Potassium measured as part of metabolic panel in millimoles per liter.
Sodium
时间窗: 2 weeks of assigned intervention
Sodium measured as part of metabolic panel in millimoles per liter.
Total Globulin
时间窗: 2 weeks of assigned intervention
Total Globulin measured as part of metabolic panel in grams per deciliter
Total Protein
时间窗: 2 weeks of assigned intervention
Total Protein measured as part of metabolic panel in grams per deciliter
Albumin/globulin ratio
时间窗: 2 weeks of assigned intervention
Albumin/globulin ratio measured as part of metabolic panel
Blood urea nitrogen/creatinine ratio
时间窗: 2 weeks of assigned intervention
Blood urea nitrogen/creatinine ratio measured as part of metabolic panel
Hematocrit
时间窗: 2 weeks of assigned intervention
Hematocrit as part of a complete blood count panel measured as percentage
Hemoglobin
时间窗: 2 weeks of assigned intervention
Hemoglobin as part of a complete blood count panel measured in grams per deciliter
Mean corpuscular volume
时间窗: 2 weeks of assigned intervention
Mean corpuscular volume as part of a complete blood count panel measured in femtoliters
Mean corpuscular hemoglobin
时间窗: 2 weeks of assigned intervention
Mean corpuscular hemoglobin as part of a complete blood count panel measured in picograms
Mean corpuscular hemoglobin concentration
时间窗: 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
时间窗: 2 weeks of assigned intervention
Red cell distribution width as part of a complete blood count panel measured as a percentage
Platelets
时间窗: 2 weeks of assigned intervention
Platelets as part of a complete blood count panel measured as a count per 1000 per microliter
Specific gravity
时间窗: 2 weeks of assigned intervention
Specific gravity as measured as part of urinalysis (no units)
pH
时间窗: 2 weeks of assigned intervention
pH as measured as part of urinalysis (no units)
Urine color
时间窗: 2 weeks of assigned intervention
Urine color as reported as part of urinalysis (no units)
Urine Appearance
时间窗: 2 weeks of assigned intervention
Urine Appearance as reported as part of urinalysis (no units)
White Blood Cell esterase
时间窗: baseline
White blood cell esterase as measured as part of urinalysis, if present
White blood cell esterase
时间窗: 2 weeks of assigned intervention
White blood cell esterase as measured as part of urinalysis, if present
Protein
时间窗: 2 weeks of assigned intervention
Protein as measured as part of urinalysis, if present
Glucose
时间窗: 2 weeks of assigned intervention
Glucose as measured as part of urinalysis, if present
Ketones
时间窗: 2 weeks of assigned intervention
Ketones as measured as part of urinalysis, if present
Occult blood
时间窗: 2 weeks of assigned intervention
Occult blood as measured as part of urinalysis, if present
Bilirubin
时间窗: 2 weeks of assigned intervention
Bilirubin as measured as part of urinalysis, if present
Urobilinogen
时间窗: 2 weeks of assigned intervention
Urobilinogen as measured as part of urinalysis in milligrams per deciliter
Microscopic examination
时间窗: 2 weeks of assigned intervention
Microscopic examination as reported as part of urinalysis, if indicated
Total Cholesterol
时间窗: 2 weeks of assigned intervention
Total Cholesterol as reported as part of lipid panel in milligrams per deciliter
Very Low-Density Lipoprotein Cholesterol
时间窗: 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
时间窗: 2 weeks of assigned intervention
Low-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter
Triglycerides
时间窗: 2 weeks of assigned intervention
Triglycerides as reported as part of lipid panel in milligrams per deciliter
High-Density Lipoprotein Cholesterol
时间窗: 2 weeks of assigned intervention
High-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter
Mood questionnaire
时间窗: 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
时间窗: 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
时间窗: 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)
Weight
时间窗: 2 weeks of assigned treatment
Body weight measured in kg
Diastolic blood pressure
时间窗: 2 weeks of assigned treatment
Diastolic blood pressure will be measured using an automated blood pressure machine in units millimeters of mercury
Bristol Chart
时间窗: 14 days of assigned treatment
Self-reported number and consistency of daily bowel movements
Skin age
时间窗: 2 weeks of assigned treatment
a quantitative skin age based on skin parameters will be determined by the 3D P Plus system
Heart rate
时间窗: baseline
Heart rate will be measured using an automated blood pressure machine in units beats per minute
Heart Rate
时间窗: 2 weeks of assigned treatment
Hear rate will be measured using an automated blood pressure machine in units beats per minute
Systolic blood pressure
时间窗: 2 weeks of assigned treatment
Systolic blood pressure will be measured using an automated blood pressure machine in units millimeters of mercury
次要结局
- Daily food diary(1 day prior to 2 week visit)
研究者
Richard Bloomer
Dean of College of Health Sciences
University of Memphis