The Effects of a Novel Nutritional Product on Nutrient Gaps and Gut Health in Adults With Occasio… (NCT06564285) | Clinical Trial Compass
CompletedNot Applicable
The Effects of a Novel Nutritional Product on Nutrient Gaps and Gut Health in Adults With Occasional Gastrointestinal Issues
United States24 participantsStarted 2024-08-28
Plain-language summary
This study is a randomized, double-blind, placebo-controlled study of N=40 adult men and women with occasional GI issues. This study to assess the effect of a novel dietary supplement on the gut microbiome, nutrient gaps, and tolerability.
Who can participate
Age range18 Years – 60 Years
SexALL
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To be eligible to participate in this study, an individual must meet all of the following criteria:
* Provide voluntary signed and dated informed consent.
* Does not have any chronic health conditions that could impact participation in this study such as oncological or psychiatric disorders.
* No known history of chronic illness or disease.
* Aged between 18 and 60 years (inclusive).
* Body Mass Index of 20-34.9 (inclusive).
* Agree to maintain existing dietary and physical activity patterns throughout the study period.
* Willing and able to comply with the study protocol.
* Self-reported gastrointestinal symptoms, such as self-reported abdominal pain, gas and bloating after meals, heartburn/acid reflux after meals, and issues with digestion.
* Must be in good general health.
* Following a stable, consistent diet pattern.
* Agree to refrain from any lifestyle changes that may affect their GI tract and IBS symptoms for the duration of the study.
* Not currently taking and not planning on introducing any product, supplement or medication aimed at gut health or nutritional gaps during the study period.
* Resides in the United States.
An individual who meets the following criteria will be excluded from participation in this study:
* Prior prescriptions for IBS or any other medication (OTC and prescription) targeting the gut.
* Taking any supplements targeting the gut in the past 30 days.
* Current IBS treatment (e.g. proton pump inhibitors, laxatives).
* Follow an extreme diet…