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Safety and Tolerability Trial of Microbial Inulinase

NCT05744700 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-09-27

No results posted yet for this study

Summary

The objectives of this clinical trial are to: 1) assess the effect of microbial inulinase on gastrointestinal symptoms in healthy participants compared to a placebo, and 2) to assess the safety and tolerability of microbial inulinase in healthy participants compared to a placebo.

Conditions

  • Digestive Health
  • Gastrointestinal Health

Interventions

DIETARY_SUPPLEMENT

Inulinase

Participants will consume one capsule containing 1,000 INU inulinase, twice daily, for 28 days. Participants will be directed to consume the capsules with their two largest meals.

DIETARY_SUPPLEMENT

Maltodextrin placebo

Participants will consume one capsule containing maltodextrin, twice daily, for 28 days. Participants will be directed to consume the capsules with their two largest meals.

Sponsors & Collaborators

  • Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

    collaborator NETWORK

  • BIO-CAT, Inc.

    lead INDUSTRY

Principal Investigators

  • Anthony Bier, MD, CCFP · Apex Trials

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-28
Primary Completion
2023-10-06
Completion
2023-10-06

Countries

  • Canada

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 NCT05744700 on ClinicalTrials.gov