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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
Sponsor:
Collaborator:
http://mynewgut.eu/partners
Information provided by (Responsible Party):
Arne Astrup, University of Copenhagen

Tracking Information
First Submitted Date  ICMJE July 15, 2014
First Posted Date  ICMJE August 13, 2014
Last Update Posted Date May 20, 2020
Study Start Date  ICMJE August 2014
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2014)
Change in gut microbiota composition [ Time Frame: Week 0, 4, 8, 12 ]
Gut microbiota composition will be analyzed by use of fecal samples.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2020)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2014)
  • 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
Current Other Pre-specified Outcome Measures
 (submitted: May 18, 2020)
  • 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
Original Other Pre-specified Outcome Measures
 (submitted: August 11, 2014)
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
 
Descriptive Information
Brief Title  ICMJE Effect of Prebiotic and PUFA on the Gut Microbiota and Metabolic Risk Markers
Official Title  ICMJE Effect of Prebiotic Fibre and Polyunsaturated Fatty Acid (PUFA) on the Gut Microbiota and Metabolic Risk Markers in a Metabolically Challenged Population
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Overweight
Intervention  ICMJE
  • Dietary Supplement: Wheat bran extract
    Patients will be provided with 15g of wheat bran extract (WBE) (Cargill R&D Centre Europe).
  • 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).
Study Arms  ICMJE
  • Experimental: High fibre diet (wheat bran extract)
    Intervention: Dietary Supplement: Wheat bran extract
  • Experimental: High PUFA diet (fish oil supplement)
    Intervention: Dietary Supplement: Fish oil
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 11, 2014)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02215343
Other Study ID Numbers  ICMJE MyNewGut, Task 3.3
Grant Agreement no: 613979 ( Other Grant/Funding Number: EU 7th Framework Programme )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arne Astrup, University of Copenhagen
Study Sponsor  ICMJE University of Copenhagen
Collaborators  ICMJE http://mynewgut.eu/partners
Investigators  ICMJE
Principal Investigator: Lesli H Larsen, PhD Department of Nutrition, Exercise and sports, University of Copenhagen
PRS Account University of Copenhagen
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP