Efficacy of Two Enzyme Cocktails in Healthy Adults

NCT06710392 | Not Yet Recruiting

• 1 other identifier: CTB2022TN225D
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Digestive; Gastrointestinal Health

Keywords

enzyme; enzyme cocktail; healthy adults; nutraceutical

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change from baseline in Stool Consistency at end of intervention

  Through study completion, an expected average of 70 days

• Change from baseline in the Stool Frequency at end of intervention

  Through study completion, an expected average of 70 days

• Change in Microbiome (faecal samples)

  Day 0 and Day 28; Day 42 and Day 70

• Body Mass Index (BMI)

  Day 0, Day 28, Day 42, and Day 70

• Total Fat Mass

  Day 0, Day 28, Day 42, and Day 70

Study Arms (4)

Digestive Enzyme Cocktail A

EXPERIMENTAL

Arm receiving investigational product A

Dietary Supplement: Enzyme Cocktail A

Digestive Enzyme Cocktail B

EXPERIMENTAL

Arm receiving investigational product B

Dietary Supplement: Enzyme Cocktail B

Placebo A

PLACEBO COMPARATOR

Arm receiving placebo A

Dietary Supplement: Placebo A

Placebo B

PLACEBO COMPARATOR

Arm receiving Placebo B

Dietary Supplement: Placebo B

Interventions

Enzyme Cocktail A DIETARY_SUPPLEMENT

Enzyme cocktail A in the form of a capsule with a daily dose of 275mg taken 3 times a day for 4 weeks.

Digestive Enzyme Cocktail A

Enzyme Cocktail B DIETARY_SUPPLEMENT

Enzyme cocktail B in the form of a capsule with a daily dose of 50mg taken 3 times a day for 4 weeks.

Digestive Enzyme Cocktail B

Placebo A DIETARY_SUPPLEMENT

Placebo A matching investigational product A given 3 times a day for 4 weeks.

Placebo A

Placebo B DIETARY_SUPPLEMENT

Placebo B matching investigational product B given 3 times a day for 4 weeks.

Placebo B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• The Archer-Daniels-Midland Company: lead
• University of North Texas, Denton, TX: collaborator

Study Sites (1)

The University of North Texas

Denton, Texas, 76201, United States

Location

Central Study Contacts

Dr. McFarlin

CONTACT

940-565-2232; brian.mcfarlin@unt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: November 29, 2024
• Study Start: December 15, 2024
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)