The Effect of Gluten on Gut Microbiome and Metabolic Health.
NCT ID: NCT01719913
Last Updated: 2013-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2012-10-31
2013-11-30
Brief Summary
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Design: A randomized, controlled, single-blinded, cross-over intervention trial consisting of two 8-week interventions periods, separated by a 6-week wash-out period. A total number of 60 participants will be included.
Intervention: low vs high gluten intake.
Detailed Description
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Measurements: Altered quantitative metagenomics at bacterial gene- and species levels is the primary outcome of this study. Secondary outcomes include metabolic and inflammatory markers, circulating appetite hormone levels,serum metabolomics, gastrointestinal transit time and intestinal permeability. Furthermore, selected control measures are included; 4-day food records and a study intervention dietary records.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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Low gluten
Poor gluten diet: Participants consume less than 5g gluten per day (estimated to correspond to a gluten intake below the 10th percentile in the population)
Low gluten
Poor gluten diet: Participants consume less than 5g gluten per day (estimated to correspond to a gluten intake below the 10th percentile in the population)
High gluten
Refined grain/ gluten rich diet : Participants consume more than 25g of gluten per day (estimated to correspond to a gluten intake around the 90th percentile in the population)
High gluten
Refined grain/ gluten rich diet : Participants consume more than 25g of gluten per day (estimated to correspond to a gluten intake around the 90th percentile in the population)
Interventions
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High gluten
Refined grain/ gluten rich diet : Participants consume more than 25g of gluten per day (estimated to correspond to a gluten intake around the 90th percentile in the population)
Low gluten
Poor gluten diet: Participants consume less than 5g gluten per day (estimated to correspond to a gluten intake below the 10th percentile in the population)
Eligibility Criteria
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Inclusion Criteria
* Abdominal obesity: waist circumference: men: ≥ 94cm; women: ≥ 80cm
* No medically prescribed diet
* Weight stable
* Intense sporting activities less than 10 h/week
* Alcohol consumption less than 14 units/week (female) and 21 units/week (male)
* Signed informed consent
* Fasting plasma glucose from 6.1 mmol/l to 6.9 mmol/l
* Reduced high density lipoprotein (HDL) cholesterol; HDL ≤ 1.03 mmol/L for men and ≤ 1.29 mmol/L for women
* Increased triglyceride (TG) \> 1.3 mmol/L
* Systolic blood pressure \> 130 mmHg
Exclusion Criteria
* Lactating (or lactating, 6 weeks ago), pregnant (or pregnant, 3 months ago) or wish to become pregnant during the study
* Participation in another biomedical trial 1 month prior to study start
* Diagnosed with any form of diabetes, celiac disease or chronic pancreatitis
* Reported chronic gastrointestinal disorders
* Antibiotic treatment for 3 month prior to study start
* Blood hemoglobin \< 7.0 mmol/l
* Blood donation within 1 month prior to study start
18 Years
65 Years
ALL
Yes
Sponsors
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Technical University of Denmark
OTHER
University of Copenhagen
OTHER
Responsible Party
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Oluf Borbye Pedersen
Scientific Director, professor
Principal Investigators
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Oluf B Pedersen, MD, DMSCi,Professor
Role: PRINCIPAL_INVESTIGATOR
University of Copenhagen
Locations
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The Novo Nordisk Foundation of Basic Metabolic Health, Section for Metabolic Genetics
Copenhagen, , Denmark
Countries
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References
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Lind MV, Lauritzen L, Vestergaard H, Hansen T, Pedersen O, Kristensen M, Ross AB. One-carbon metabolism markers are associated with cardiometabolic risk factors. Nutr Metab Cardiovasc Dis. 2018 Apr;28(4):402-410. doi: 10.1016/j.numecd.2018.01.005. Epub 2018 Jan 31.
Related Links
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Related Info
Other Identifiers
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NNF-CBMR 3861-34275
Identifier Type: -
Identifier Source: org_study_id