Efficacy of Two Enzyme Cocktails in Healthy Adults (ElZyme)

Evaluate the Safety and Efficacy of Two Enzyme Cocktails in Healthy Adults With Subclinical Mild to Moderate Gastrointestinal Complaints

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.

Study Overview

• Status: Terminated
• Conditions: Gastrointestinal Health; Digestive
• Intervention / Treatment: Dietary supplement: Enzyme Cocktail A; Dietary supplement: Enzyme Cocktail B; Dietary supplement: Placebo A; Dietary supplement: Placebo B

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Denton, Texas, United States, 76201
      • The University of North Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digestive Enzyme Cocktail A; Arm receiving investigational product A	Dietary supplement: 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.
Experimental: Digestive Enzyme Cocktail B; Arm receiving investigational product B	Dietary supplement: 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 Comparator: Placebo A; Arm receiving placebo A	Dietary supplement: Placebo A; Placebo A matching investigational product A given 3 times a day for 4 weeks.
Placebo Comparator: Placebo B; Arm receiving Placebo B	Dietary supplement: Placebo B; Placebo B matching investigational product B given 3 times a day for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Gastrointestinal Symptoms Rating Scale - Irritable Bowel Syndrome (GSRS-IBS)	Change in GSRS-IBS total score from baseline to end of intervention. Each question is rated on a 7 point Likert scale with higher scores representing more troublesome symptoms. Questionnaire collected weekly from baseline through study completion at the end of week 12.	From baseline to the end of intervention 4 weeks later.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Stool Consistency at end of intervention	Difference in weekly self reported stool consistency, as measured by the Bristol Stool Form Scale (BSFS) on a daily basis. BSFS max score 7 - lower scores indicate constipation, higher scores indicate diarrhea.	Through study completion, an expected average of 70 days
Change from baseline in the Stool Frequency at end of intervention	Change in weekly average stool frequency throughout the period between baseline and end of intervention.	Through study completion, an expected average of 70 days
Change in Microbiome (faecal samples)	Change in stool microbiome between baseline and end of intervention for each of cross over runs (Change between day 0 and day 28, change between day 42 and 70)	Day 0 and Day 28; Day 42 and Day 70
Body Mass Index (BMI)	Participants whole-body weight [kg] and height [m] will be measured and BMI will be calculated as kg/m^2	Day 0, Day 28, Day 42, and Day 70
Total Fat Mass	Participants total fat mass (kg) will be tested using a BIA scale.	Day 0, Day 28, Day 42, and Day 70
Food Intake	Food intake is measured by the NHANES Food Frequency Questionnaire (NHANES-FFQ), which collects data to measure habitual food intake at baseline.	Day 0
Positive and Negative Affect Schedule (PANAS-SF)	The PANAS-SF is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much).	Day 0, Day 28, Day 42, and Day 70

Collaborators and Investigators

• Sponsor: The Archer-Daniels-Midland Company
• Collaborators: University of North Texas, Denton, TX

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2025
• Primary Completion (Actual): February 28, 2026
• Study Completion (Actual): February 28, 2026

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: November 27, 2024
• First Posted (Actual): November 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: enzyme; nutraceutical; healthy adults; enzyme cocktail
• Other Study ID Numbers: CTB2022TN225D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No