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Effects of Barley Based Food Products on Metabolism and Gut Microflora

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ClinicalTrials.gov Identifier: NCT02427555
Recruitment Status : Completed
First Posted : April 28, 2015
Last Update Posted : May 17, 2016
Sponsor:
Collaborator:
Göteborg University
Information provided by (Responsible Party):
Anne Nilsson, Lund University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Other: Barley kernel bread Other: white wheat bread Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Barley Based Food Products on Metabolism and Gut Microflora
Study Start Date : April 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

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




Primary Outcome Measures :
  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



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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427555


Locations
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Sweden
Food for Health Science Centre, Medicon Village, Lund University
Lund, Sweden, , SE-223 81 LUND
Sponsors and Collaborators
Lund University
Göteborg University
Investigators
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Principal Investigator: Anne Nilsson, PhD Food for Health Science Centre, Medicon Village, Lund University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anne Nilsson, Associate professor, PhD, Lund University
ClinicalTrials.gov Identifier: NCT02427555     History of Changes
Other Study ID Numbers: AFC-Y8-2015
First Posted: April 28, 2015    Key Record Dates
Last Update Posted: May 17, 2016
Last Verified: May 2016