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Effect of 6 Weeks Daily Consumption of a Cereal-based Juice Beverage on Gastrointestinal Health

NCT03046667 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2017-12-13

No results posted yet for this study

Summary

The project is a randomized, 2-way, blinded parallel trial in which 56 healthy adults of both genders with frequent occurrence of stomach trouble.This intervention trial with 6 weeks of daily intake β-glucans will be carried out with a beverage containing β-glucans and a control beverage without β-glucans. The primary aim is to investigate whether β-glucans from barley has an effect on stomach and intestinal health, including stool volume and frequency. Microbiota, concentrations of short chain fatty acids (butyrate, propionate, acetate), calprotectin, and energy and fat content in feces. Furthermore, blood pressure and exhaled hydrogen and methane, before and after the intervention, subjective perception of gastrointestinal problems and digestion as well as the participants' attitudes towards functional foods are measured using Visual Analog Scale (VAS).

Further, specific metabolites of β-glucans in urine (exploratory endpoint) and certain toxic metabolites from the microbiota using metabolite profiling (metabolomics) are also analyzed

Conditions

  • Irritable Bowel

Interventions

DIETARY_SUPPLEMENT

Barley β-glucan

The test beverages with Barley β-glucan is consumed by the participants for the first time at the trial site, followed by a 1 week running-in period were the participants was ingesting half a dose of test drinks. Subsequent were a full dose of the test drinks consumed for 5 weeks. In total was the test drinks consumed for 6 weeks.

DIETARY_SUPPLEMENT

Control

The control beverages is consumed by the participants for the first time at the trial site, followed by a 1 week running-in period were the participants was ingesting half a dose of test drinks. Subsequent were a full dose of the test drinks

Sponsors & Collaborators

  • Carlsberg Group

    collaborator UNKNOWN

  • University of Copenhagen

    lead OTHER

Principal Investigators

  • Lars Ove Dragsted, PhD · University of Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-02-08
Primary Completion
2017-07-20
Completion
2017-12-11

Countries

  • Denmark

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 NCT03046667 on ClinicalTrials.gov