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Completed

NCT Number: NCT02427555

Effects of Barley Based Food Products on Metabolism and Gut Microflora

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.

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Key information

Conditions

Healthy Subjects

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Food for Health Science Centre, Medicon Village, Lund University

Lund, , SE-223 81 LUND, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Barley kernel bread

Other

3 days intervention with barley kernel bread

white wheat bread

Other

3 days intervention with white wheat bread

Primary outcomes

  1. 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

  2. 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

  3. nucleotide polymorphisms (SNP in TCF7L2)

    Time frame: at baseline

    investigate nucleotide polymorphisms that associate with cardiometabolic traits, in particular the SNP in TCF7L2

Sponsors and collaborators

Lead sponsor

Lund University

Other

Collaborators

  • Göteborg University

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 28, 2015
Registry last updated
May 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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