Effect of Prebiotic and PUFA on the Gut Microbiota and Metabolic Risk Markers (MyNewGut)
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|ClinicalTrials.gov Identifier: NCT02215343|
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : May 20, 2020
The main objective of this study is to investigate in detail how a high-(prebiotic)fibre diet and a high-PUFA diet affect the gut microbiota composition in a metabolic challenged population, and if the diet-induced modulation of the gut microbiota mediates changes in metabolic risk markers.
Intake of both experimental diets over 4 weeks are expected to induce beneficial changes in the gut microbiota composition and to affect markers for insulin sensitivity, lipid metabolism and inflammation. The investigators hypothesize that the effect of both interventions on the metabolic risk markers will be partly mediated by the diet-induced changes in the gut microbiota composition.
|Condition or disease||Intervention/treatment||Phase|
|Overweight||Dietary Supplement: Wheat bran extract Dietary Supplement: Fish oil||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Prebiotic Fibre and Polyunsaturated Fatty Acid (PUFA) on the Gut Microbiota and Metabolic Risk Markers in a Metabolically Challenged Population|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
|Experimental: High fibre diet (wheat bran extract)||
Dietary Supplement: Wheat bran extract
Patients will be provided with 15g of wheat bran extract (WBE) (Cargill R&D Centre Europe).
|Experimental: High PUFA diet (fish oil supplement)||
Dietary Supplement: Fish oil
Patients will be provided with a fish oil supplement (capsules), containing 3-4g of N-3 fatty acids (Axellus A/S, Ishøj, Denmark).
- Change in gut microbiota composition [ Time Frame: Week 0, 4, 8, 12 ]Gut microbiota composition will be analyzed by use of fecal samples.
- Change in markers for insulin sensitivity [ Time Frame: Week 0, 4, 8, 12 ]Will be measured by use of fasting blood samples
- Change in markers for lipid metabolism [ Time Frame: Week 0, 4, 8, 12 ]Will be measured by use of fasting blood samples
- Change in markers for inflammation [ Time Frame: Week 0, 4, 8, 12 ]Will be measured by use of fasting blood samples
- Faecal SCFA and bile acid composition [ Time Frame: Week 0, 4, 8, 12 ]Will be analyzed by use of fecal samples.
- Lipidomics [ Time Frame: Week 0, 4, 8, 12 ]Will be analyzed by use of fasting blood samples and fecal samples.
- Metabolomics [ Time Frame: Week 0, 4, 8, 12 ]Will be analyzed by use of fasting blood samples, urine and fecal samples.
- Change in energy expenditure [ Time Frame: Week 0, 4, 8, 12 ]Resting energy expenditure will be measured by indirect calorimetry in a ventilated hood system
- Gene expression [ Time Frame: Week 0, 4, 8, 12 ]Adipose tissue biopsies will be used for epigenetic analyses, gene and protein expression (no whole genome or exome sequencing).
- Compliances markers [ Time Frame: Week 0, 4, 8, 12 ]Compliance will be evaluated from 3-days diet registration and self-reported intake of dietary supplements, PUFA complance markes (fatty acid composition) and body composition
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): NCT02215343
|Department of Nutrition, Exercise and Sports, University of Copenhagen|
|Frederiksberg, Denmark, 1958|
|Principal Investigator:||Lesli H Larsen, PhD||Department of Nutrition, Exercise and sports, University of Copenhagen|