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A Double Blind Study on the Gastrointestinal Effects of Arabinoxylan (Leaf Fiber Extract).

NCT04100460 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2019-09-24

No results posted yet for this study

Summary

The objective of this study is to investigate the effect on Arabinoxylan on gastrointestinal (GI) tolerance, bowel habits, and microbiota in adults. The study is a randomized, placebo-controlled, crossover, single-center trial with 3 study periods separated by minimum 2-week washout periods. 45 healthy adults will be recruited for the trial. Participants will be required to drink a beverage twice a day for 3 weeks during each study period. The beverage will contain either approximately 7.25 grams of Arabinoxylan leaf fiber extract per day, or approximately 14.5 grams of Arabinoxylan leaf fiber extract per day, or will not contain any Arabinoxylan (control). Subjects will record their bowel movements daily, fill out daily questionnaires about their gastrointestinal systems, and record their food intake at specified times during the study. Stool samples will also be collected prior to and at the end of each study period for analysis of bacteria composition.

Conditions

  • Gastrointestinal Tolerance

Interventions

DIETARY_SUPPLEMENT

7.25 grams of Arabinoxylan leaf fiber extract

Participants are given 7.25 grams of Arabinoxylan daily

DIETARY_SUPPLEMENT

14.5 grams of Arabinoxylan leaf fiber extract

Participants are given 14.5 grams of Arabinoxylan daily

DIETARY_SUPPLEMENT

Control - No Arabinoxylan

Participants are given no Arabinoxylan

Sponsors & Collaborators

  • Biofortis, Merieux NutriSciences

    collaborator INDUSTRY

  • Comet Bio Inc.

    lead INDUSTRY

Principal Investigators

  • Kathleen Kelley, MD · Biofortis, Merieux NutriSciences

  • Rich Troyer · Comet Bio Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-30
Primary Completion
2020-03-31
Completion
2020-05-31

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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 NCT04100460 on ClinicalTrials.gov