Effects of Barley Based Food Products on Metabolism and Gut Microflora

May 16, 2016 updated by: Anne Nilsson, Lund University
The main objective is to investigate gut microflora composition in relation to cardiometabolic risk markers, and to investigate the effects of 3 days intervention with a barley kernel based product on these variables.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

100 subjects were invited to deliver faecal samples. From this cohort 40 subjects were chosen based on their gut microflora composition to participate in the Barley intervention.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden, , SE-223 81 LUND
        • Food for Health Science Centre, Medicon Village, Lund University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy men and women between 50-79 years and
  • BMI between 19-28.

Exclusion Criteria:

  • fasting blood glucose concentrations > 6,1 mmol/L,
  • known metabolic disorders or gastrointestinal diseases or other disorders that can interfere with the results of the study.
  • furthermore, the subjects should be non-smokers and
  • consume a normal (non-vegetarian) diet as is recommended by the Nordic dietary guidelines.
  • antibiotics or probiotics should not have been taken during four weeks prior to faeces donation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Barley kernel bread
Other: Barley kernel bread
3 days intervention with barley kernel bread
Sham Comparator: Whit wheat flour bread
Other: white wheat bread
3 days intervention with white wheat bread

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in glucose regulation
Time Frame: Changes in fasting and postprandial blood glucose concentrations after 3 days intervention with a barley based bread in comparison to 3 days intervention with a white wheat based bread
blood glucose concentrations are measured fasting and postprandially a standardised breakfast after interventions with barley based bread and white wheat bread, respectively
Changes in fasting and postprandial blood glucose concentrations after 3 days intervention with a barley based bread in comparison to 3 days intervention with a white wheat based bread
Changes in colonic microbiota composition after intervention with barley
Time Frame: Changes in colonic microbiota composition after 3 days intervention with a barley based bread in comparison to 3 days intervention with a white wheat based bread
Gut microbiota composition are characterised after interventions with barley based bread and white wheat bread, respectively
Changes in colonic microbiota composition after 3 days intervention with a barley based bread in comparison to 3 days intervention with a white wheat based bread
nucleotide polymorphisms (SNP in TCF7L2)
Time Frame: at baseline
investigate nucleotide polymorphisms that associate with cardiometabolic traits, in particular the SNP in TCF7L2
at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University

Collaborators

Göteborg University

Investigators

  • Principal Investigator: Anne Nilsson, PhD, Food for Health Science Centre, Medicon Village, Lund University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

April 17, 2015

First Submitted That Met QC Criteria

April 22, 2015

First Posted (Estimate)

April 28, 2015

Study Record Updates

Last Update Posted (Estimate)

May 17, 2016

Last Update Submitted That Met QC Criteria

May 16, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • AFC-Y8-2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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