Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Prebiotic and PUFA on the Gut Microbiota and Metabolic Risk Markers (MyNewGut)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02215343
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : May 20, 2020
Sponsor:
Collaborator:
http://mynewgut.eu/partners
Information provided by (Responsible Party):
Arne Astrup, University of Copenhagen

Brief Summary:

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil

Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. Change in gut microbiota composition [ Time Frame: Week 0, 4, 8, 12 ]
    Gut microbiota composition will be analyzed by use of fecal samples.


Secondary Outcome Measures :
  1. Change in markers for insulin sensitivity [ Time Frame: Week 0, 4, 8, 12 ]
    Will be measured by use of fasting blood samples

  2. Change in markers for lipid metabolism [ Time Frame: Week 0, 4, 8, 12 ]
    Will be measured by use of fasting blood samples

  3. Change in markers for inflammation [ Time Frame: Week 0, 4, 8, 12 ]
    Will be measured by use of fasting blood samples

  4. Faecal SCFA and bile acid composition [ Time Frame: Week 0, 4, 8, 12 ]
    Will be analyzed by use of fecal samples.

  5. Lipidomics [ Time Frame: Week 0, 4, 8, 12 ]
    Will be analyzed by use of fasting blood samples and fecal samples.

  6. Metabolomics [ Time Frame: Week 0, 4, 8, 12 ]
    Will be analyzed by use of fasting blood samples, urine and fecal samples.


Other Outcome Measures:
  1. 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

  2. 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).

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI: 25-40 kg/m2
  • Non-smoking
  • Indices of the Metabolic Syndrome defined by the International Diabetes Federation (IDF 2006):

Central obesity (waist circumference; men: ≥94 cm and women: ≥80 cm) + any one of the following; raised triglyceride level (≥1.7 mmol/L), reduced HDL cholesterol (men: <1.03 mmol/L, women: <1.29 mmol/L), raised BP (systolic ≥130 mm Hg or diastolic ≥85 mm Hg) or raised fasting plasma glucose (≥5.6 mmol/L).

Exclusion Criteria:

  • Use of antibiotics
  • Weight change >3 kg 2 months prior to study start
  • Intensive physical training/ elite athlete
  • Medication for dyslipidemia, type 2 diabetes or elevated blood pressure
  • Dietary supplements with pro/prebiotics, dietary fibre or fish oil supplement
  • Lactation, pregnancy or planning of pregnancy during the study
  • Gastro intestinal and liver disorders
  • Chronic inflammatory disorders
  • Diagnosed psychiatric disorder including treatment required depression
  • Surgical treatment of obesity and abdominal surgery

Information from the National Library of Medicine

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


Locations
Layout table for location information
Denmark
Department of Nutrition, Exercise and Sports, University of Copenhagen
Frederiksberg, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
http://mynewgut.eu/partners
Investigators
Layout table for investigator information
Principal Investigator: Lesli H Larsen, PhD Department of Nutrition, Exercise and sports, University of Copenhagen
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Arne Astrup, Professor, Dr.Med., University of Copenhagen
ClinicalTrials.gov Identifier: NCT02215343    
Other Study ID Numbers: MyNewGut, Task 3.3
Grant Agreement no: 613979 ( Other Grant/Funding Number: EU 7th Framework Programme )
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Additional relevant MeSH terms:
Layout table for MeSH terms
Overweight
Body Weight