Clinical trial NCT06710392: Efficacy of Two Enzyme Cocktails in Healthy Adults
Official title: Evaluate the Safety and Efficacy of Two Enzyme Cocktails in Healthy Adults With Subclinical Mild to Moderate Gastrointestinal Complaints
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Digestive
Gastrointestinal Health
Keywords: enzyme
enzyme cocktail
healthy adults
nutraceutical
Lead sponsor: The Archer-Daniels-Midland Company
Sponsor class: INDUSTRY
Collaborators: name: University of North Texas, Denton, TX
First posted: 2024-11-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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 criteria: 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 chronic disease (i.e. Diabetes, Cardiovascular, etc.)
* Doctor diagnosed immunodeficiency
* Current use of doctor prescribed immunosuppressive agents (corticosteroids, methotrexate, etc.)
* Pregnancy, 6 months postpartum period, or current breastfeeding
* Women of childbearing age planning pregnancy during the course of the study

Primary outcomes:
measure: Change in the Gastrointestinal Symptoms Rating Scale - Irritable Bowel Syndrome (GSRS-IBS)
timeFrame: From baseline to the end of intervention 4 weeks later.
Secondary outcomes:
measure: Change from baseline in Stool Consistency at end of intervention
timeFrame: Through study completion, an expected average of 70 days
measure: Change from baseline in the Stool Frequency at end of intervention
timeFrame: Through study completion, an expected average of 70 days
measure: Change in Microbiome (faecal samples)
timeFrame: Day 0 and Day 28; Day 42 and Day 70
measure: Body Mass Index (BMI)
timeFrame: Day 0, Day 28, Day 42, and Day 70
measure: Total Fat Mass
timeFrame: Day 0, Day 28, Day 42, and Day 70
measure: Food Intake
timeFrame: Day 0
measure: Positive and Negative Affect Schedule (PANAS-SF)
timeFrame: Day 0, Day 28, Day 42, and Day 70
Other outcomes:
Locations:
city: Denton
country: United States
facility: The University of North Texas
state: Texas
Study officials:
References: