Evaluate the Safety and Efficacy of Two Enzyme Cocktails in Healthy Adults With Subclinical Mild to Moderate Gastrointestinal Complaints
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.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
Exclusion Criteria: * Presence of a serious congenital anomaly or chronic medical condition that would contraindicate participation, including history of major gastrointestinal surgery, chronic gastrointestinal illness, abnormal intestinal anatomy or significant abdominal disorder * Having taken oral antibiotics in the previous 3-months or if they start antibiotics during the study * Currently or having taken a prebiotic, probiotic, or digestive enzyme supplement in the previous 3-months * Currently consuming 1 or more servings of fermented foods or yogurt on a daily basis * Doctor diagnosed…
Interventions
- Dietary SupplementEnzyme 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.
- Dietary SupplementEnzyme 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.
- Dietary SupplementPlacebo A
Placebo A matching investigational product A given 3 times a day for 4 weeks.
- Dietary SupplementPlacebo B
Placebo B matching investigational product B given 3 times a day for 4 weeks.
Location
- The University of North TexasDenton, Texas