Effects of Barley Based Food Products on Metabolism and Gut Microflora
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 17, 2015
CompletedFirst Posted
Study publicly available on registry
April 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedMay 17, 2016
May 1, 2016
1.1 years
April 17, 2015
May 16, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
Changes in glucose regulation
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
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)
investigate nucleotide polymorphisms that associate with cardiometabolic traits, in particular the SNP in TCF7L2
at baseline
Study Arms (2)
Barley kernel bread
EXPERIMENTALWhit wheat flour bread
SHAM COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- healthy men and women between 50-79 years and
- BMI between 19-28.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lund Universitylead
- Göteborg Universitycollaborator
Study Sites (1)
Food for Health Science Centre, Medicon Village, Lund University
Lund, , SE-223 81 LUND, Sweden
Related Publications (1)
Sandberg J, Kovatcheva-Datchary P, Bjorck I, Backhed F, Nilsson A. Abundance of gut Prevotella at baseline and metabolic response to barley prebiotics. Eur J Nutr. 2019 Sep;58(6):2365-2376. doi: 10.1007/s00394-018-1788-9. Epub 2018 Jul 25.
PMID: 30046942DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Anne Nilsson, PhD
Food for Health Science Centre, Medicon Village, Lund University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor, PhD
Study Record Dates
First Submitted
April 17, 2015
First Posted
April 28, 2015
Study Start
April 1, 2015
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
May 17, 2016
Record last verified: 2016-05