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

Обзор

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.

Вмешательства

• Пищевая добавка Dietary supplement for digestive health
  Dietary supplement contains cascara sagrada bark powder, cape aloe leaves extract, senna leaf powder, frangula bark powder fennel seed powder, bentonite clay, burdock root powder, licorice root extract, slippery elm bark powder, Capiscum annuum L. Fruit powder, milk thistle seed powder, hydroxypropyl methylcellulose, and silicon dioxide.
• Пищевая добавка placebo capsule
  Contains hydroxypropyl methylcellulose and cellulose

Первичные конечные точки

• Alanine transaminase [Срок оценки: baseline]
• Alanine transaminase [Срок оценки: 2 weeks of assigned intervention]
• Aspartate transferase [Срок оценки: baseline]
• Aspartate transferase [Срок оценки: 2 weeks of assigned intervention]
• Albumin [Срок оценки: baseline]
• Albumin [Срок оценки: 2 weeks of assigned intervention]
• Alkaline phosphatase [Срок оценки: baseline]
• Alkaline phosphatase [Срок оценки: 2 weeks of assigned intervention]
• Total bilirubin [Срок оценки: baseline]
• Total Bilirubin [Срок оценки: 2 weeks of assigned intervention]

Вторичные конечные точки (6)

• Daily food diary [Срок оценки: 3 days prior to baseline visit]
• Daily food diary [Срок оценки: 2 days prior to baseline visit]
• Daily food diary [Срок оценки: 1 day prior to baseline visit]
• Daily food diary [Срок оценки: 3 days prior to 2 week visit]
• Daily food diary [Срок оценки: 2 days prior to 2 week visit]
• Daily food diary [Срок оценки: 1 day prior to 2 week visit]

Критерии участия

Критерии включения

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

Критерии исключения

• pregnant, planning to become pregnant, or breastfeeding
• sensitivity or allergic to any components of the study product (cascara sagrada bark powder, cape aloe leaves extract, senna leaf powder, frangula bark powder fennel seed powder, bentonite clay, burdock root powder, licorice root extract, slippery elm bark powder, Capiscum annuum L. Fruit powder, milk thistle seed powder, hydroxypropyl methylcellulose, cellulose, and silicon dioxide).
• experienced a severe allergic reaction that resulted in emergency care
• diagnosed with medical disorders linked to digestive/gut health such as celiac disease, crohn's disease, gastroesophageal reflux disease, heartburn, irritable bowel syndrome, ulcerative colitis, ulcers, etcetera.
• experiencing regular diarrhea
• active infection or illness
• diabetic
• hypertensive
• cardiovascular disease
• breast, uterine, or ovarian cancer
• uterine fibroids or endometriosis
• taking medications or supplements that may alter gut health including but not limited to diuretics, laxatives, anti-diarrheal, anticholinergic agents, or antispasmodic agents.
• previous adverse experience with laxatives
• taking medications known to interact with the dietary supplement's ingredients including blood pressure medications, anticoagulants, antiplatelets, blood thinners, cholesterol-lowering medications, diuretics, water pills, estrogen based contraceptives, non-steroidal anti-inflammatory drugs, digoxin, corticosteroids, Monoamine oxidase inhibitors, insulin, medications processed in the liver, diclofenac, fluvastatin, glipizide, ibuprofen, piroxicam, phenytoin, phenobarbital, or secobarbital.
• tobacco user
• strenuous activity within 24 hours of testing visits
• caffeine within 24 hours of testing visit
• alcohol within 24 hours of testing visit

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Center for Nutraceutical and Dietary Supplement Research — Memphis

Идентификаторы

NCT: NCT07215351 · PRO-FY2025-554

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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