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Microbial Enzyme Impact on Postprandial Nutrient Levels and Gastrointestinal Symptoms in Healthy Adults

NCT05211440 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-09-18

No results posted yet for this study

Summary

The primary objective of this study is to investigate the acute effects of a microbial multi-enzyme mixture ("BC-006") on postprandial nutrient levels in healthy, middle-aged to older adults during a mixed meal tolerance test. Additionally, the effects of twice daily consumption of BC-006 and placebo for 3 weeks on abdominal bloating, flatulence, bowel function, and sleep quality will be measured.

Conditions

  • Digestive Health
  • Gastrointestinal Health

Interventions

DIETARY_SUPPLEMENT

Placebo + Meal

Subjects will be directed to consume 1 placebo capsule containing maltodextrin, twice daily, for 21 days. Subjects will be directed to consume the capsules with their two largest meals, in between the third and second bites of food. During the MMTT, a placebo capsule will be consumed with a standardized test meal containing chicken, peas, potatoes, and butter.

DIETARY_SUPPLEMENT

BC-006 + Meal

Subjects will be directed to consume 1 capsule containing BC-006, twice daily, for 21 days. Subjects will be directed to consume the capsules with their two largest meals, in between the third and second bites of food. During the MMTT, a BC-006 capsule will be consumed with a standardized test meal containing chicken, peas, potatoes, and butter.

Sponsors & Collaborators

  • BIO-CAT, Inc.

    collaborator INDUSTRY

  • University of Illinois at Urbana-Champaign

    lead OTHER

Principal Investigators

  • Nicholas A Burd, PhD · University of Illinois Urbana-Champaign

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-18
Primary Completion
2023-08-25
Completion
2023-08-25

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05211440 on ClinicalTrials.gov