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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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30 May 2016 |
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Main ID: |
NCT02427555 |
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Date of registration:
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17/04/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effects of Barley Based Food Products on Metabolism and Gut Microflora
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Scientific title:
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Effects of Barley Based Food Products on Metabolism and Gut Microflora |
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Date of first enrolment:
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April 2015 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02427555 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Anne Nilsson, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Food for Health Science Centre, Medicon Village, Lund University |
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Key inclusion & exclusion 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.
Age minimum:
50 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy Subjects
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Intervention(s)
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Other: Barley kernel bread
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Other: white wheat bread
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Primary Outcome(s)
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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]
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nucleotide polymorphisms (SNP in TCF7L2)
[Time Frame: at baseline]
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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]
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Secondary ID(s)
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AFC-Y8-2015
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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