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

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

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.

Study Overview

• Status: Completed
• Conditions: Overweight
• Intervention / Treatment: Dietary supplement: Wheat bran extract; Dietary supplement: Fish oil

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Frederiksberg, Denmark, 1958
    • Department of Nutrition, Exercise and Sports, University of Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in gut microbiota composition	Gut microbiota composition will be analyzed by use of fecal samples.	Week 0, 4, 8, 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in markers for insulin sensitivity	Will be measured by use of fasting blood samples	Week 0, 4, 8, 12
Change in markers for lipid metabolism	Will be measured by use of fasting blood samples	Week 0, 4, 8, 12
Change in markers for inflammation	Will be measured by use of fasting blood samples	Week 0, 4, 8, 12
Faecal SCFA and bile acid composition	Will be analyzed by use of fecal samples.	Week 0, 4, 8, 12
Lipidomics	Will be analyzed by use of fasting blood samples and fecal samples.	Week 0, 4, 8, 12
Metabolomics	Will be analyzed by use of fasting blood samples, urine and fecal samples.	Week 0, 4, 8, 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in energy expenditure	Resting energy expenditure will be measured by indirect calorimetry in a ventilated hood system	Week 0, 4, 8, 12
Gene expression	Adipose tissue biopsies will be used for epigenetic analyses, gene and protein expression (no whole genome or exome sequencing).	Week 0, 4, 8, 12
Compliances markers	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	Week 0, 4, 8, 12

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: http://mynewgut.eu/partners
• Investigators: Principal Investigator: Lesli H Larsen, PhD, Department of Nutrition, Exercise and Sports, University of Copenhagen

Publications and helpful links

General Publications

• Benitez-Paez A, Kjolbaek L, Gomez Del Pulgar EM, Brahe LK, Astrup A, Matysik S, Schott HF, Krautbauer S, Liebisch G, Boberska J, Claus S, Rampelli S, Brigidi P, Larsen LH, Sanz Y. A Multi-omics Approach to Unraveling the Microbiome-Mediated Effects of Arabinoxylan Oligosaccharides in Overweight Humans. mSystems. 2019 May 28;4(4):e00209-19. doi: 10.1128/mSystems.00209-19.
• Kjolbaek L, Benitez-Paez A, Gomez Del Pulgar EM, Brahe LK, Liebisch G, Matysik S, Rampelli S, Vermeiren J, Brigidi P, Larsen LH, Astrup A, Sanz Y. Arabinoxylan oligosaccharides and polyunsaturated fatty acid effects on gut microbiota and metabolic markers in overweight individuals with signs of metabolic syndrome: A randomized cross-over trial. Clin Nutr. 2020 Jan;39(1):67-79. doi: 10.1016/j.clnu.2019.01.012. Epub 2019 Feb 19.

Helpful Links

• Project website

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: July 15, 2014
• First Submitted That Met QC Criteria: August 11, 2014
• First Posted (Estimate): August 13, 2014

Study Record Updates

• Last Update Posted (Actual): May 20, 2020
• Last Update Submitted That Met QC Criteria: May 18, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: MyNewGut, Task 3.3; Grant Agreement no: 613979 (Other Grant/Funding Number: EU 7th Framework Programme)