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Efficacy of Two Enzyme Cocktails in Healthy Adults
Sponsor: The Archer-Daniels-Midland Company
Summary
The goal of this study is to determine the safety and efficacy of two enzyme cocktails in healthy adults with mild to moderate gastrointestinal discomfort. The main question aims to answer whether a 4-week administration of an enzyme cocktail can improve how the participant feels about their gut health. This is done by completing a weekly questionnaire, and the results are compared between the 4 weeks the participants are on a placebo and the 4 weeks the participants are on the enzyme cocktail. Participants will also provide a stool sample at the start and end of each treatment. Stool samples will collected and stored in case further microbiome analysis is warranted.
Official title: Evaluate the Safety and Efficacy of Two Enzyme Cocktails in Healthy Adults With Subclinical Mild to Moderate Gastrointestinal Complaints
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2024-12-15
Completion Date
2025-11-30
Last Updated
2024-11-29
Healthy Volunteers
Yes
Conditions
Interventions
Enzyme Cocktail A
Enzyme cocktail A in the form of a capsule with a daily dose of 275mg taken 3 times a day for 4 weeks.
Enzyme Cocktail B
Enzyme cocktail B in the form of a capsule with a daily dose of 50mg taken 3 times a day for 4 weeks.
Placebo A
Placebo A matching investigational product A given 3 times a day for 4 weeks.
Placebo B
Placebo B matching investigational product B given 3 times a day for 4 weeks.
Locations (1)
The University of North Texas
Denton, Texas, United States