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Completed

NCT Number: NCT02215343

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

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition, Exercise and Sports, University of Copenhagen

Frederiksberg, 1958, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wheat Bran Extract

Dietary Supplement

Patients will be provided with 15g of wheat bran extract (WBE) (Cargill R&D Centre Europe).

Fish Oil

Dietary Supplement

Patients will be provided with a fish oil supplement (capsules), containing 3-4g of N-3 fatty acids (Axellus A/S, Ishøj, Denmark).

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • http://mynewgut.eu/partners

Registry information

Official study title

Effect of Prebiotic Fibre and Polyunsaturated Fatty Acid (PUFA) on the Gut Microbiota and Metabolic Risk Markers in a Metabolically Challenged Population

Acronym: MyNewGut

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 13, 2014
Registry last updated
May 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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