Effects of Barley Based Food Products on Metabolism and Gut Microflora

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Barley Based Food Products on Metabolism and Gut Microflora

Conditions
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Healthy Subjects

Intervention / Treatment
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* Other: Barley kernel bread
* Other: white wheat bread


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Barley kernel bread<br> | Other: Barley kernel bread<br>* 3 days intervention with barley kernel bread<br>|
| Sham Comparator: Whit wheat flour bread<br> | Other: white wheat bread<br>* 3 days intervention with white wheat bread<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |