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

Primary Purpose

Overweight

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Wheat bran extract

Fish oil

About this trial

This is an interventional prevention trial for Overweight

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Nutrition, Exercise and Sports, University of Copenhagen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

High fibre diet (wheat bran extract)

High PUFA diet (fish oil supplement)

Arm Description

Outcomes

Primary Outcome Measures

Change in gut microbiota composition

Gut microbiota composition will be analyzed by use of fecal samples.

Secondary Outcome Measures

Change in markers for insulin sensitivity

Will be measured by use of fasting blood samples

Change in markers for lipid metabolism

Will be measured by use of fasting blood samples

Change in markers for inflammation

Will be measured by use of fasting blood samples

Faecal SCFA and bile acid composition

Will be analyzed by use of fecal samples.

Lipidomics

Will be analyzed by use of fasting blood samples and fecal samples.

Metabolomics

Will be analyzed by use of fasting blood samples, urine and fecal samples.

Full Information

NCT ID

NCT02215343

First Posted

July 15, 2014

Last Updated

May 18, 2020

Sponsor

University of Copenhagen

Collaborators

http://mynewgut.eu/partners

1. Study Identification

Unique Protocol Identification Number

NCT02215343

Brief Title

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

Acronym

MyNewGut

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 Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

August 2014 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Copenhagen

Collaborators

http://mynewgut.eu/partners

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High fibre diet (wheat bran extract)

Arm Type

Experimental

Arm Title

High PUFA diet (fish oil supplement)

Arm Type

Experimental

Intervention Type

Dietary Supplement

Intervention Name(s)

Wheat bran extract

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Fish oil

Intervention Description

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 Measure Information:

Title

Change in gut microbiota composition

Description

Gut microbiota composition will be analyzed by use of fecal samples.

Time Frame

Week 0, 4, 8, 12

Secondary Outcome Measure Information:

Title

Change in markers for insulin sensitivity

Description

Will be measured by use of fasting blood samples

Time Frame

Week 0, 4, 8, 12

Title

Change in markers for lipid metabolism

Description

Will be measured by use of fasting blood samples

Time Frame

Week 0, 4, 8, 12

Title

Change in markers for inflammation

Description

Will be measured by use of fasting blood samples

Time Frame

Week 0, 4, 8, 12

Title

Faecal SCFA and bile acid composition

Description

Will be analyzed by use of fecal samples.

Time Frame

Week 0, 4, 8, 12

Title

Lipidomics

Description

Will be analyzed by use of fasting blood samples and fecal samples.

Time Frame

Week 0, 4, 8, 12

Title

Metabolomics

Description

Will be analyzed by use of fasting blood samples, urine and fecal samples.

Time Frame

Week 0, 4, 8, 12

Other Pre-specified Outcome Measures:

Title

Change in energy expenditure

Description

Resting energy expenditure will be measured by indirect calorimetry in a ventilated hood system

Time Frame

Week 0, 4, 8, 12

Title

Gene expression

Description

Adipose tissue biopsies will be used for epigenetic analyses, gene and protein expression (no whole genome or exome sequencing).

Time Frame

Week 0, 4, 8, 12

Title

Compliances markers

Description

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

Time Frame

Week 0, 4, 8, 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lesli H Larsen, PhD

Organizational Affiliation

Department of Nutrition, Exercise and sports, University of Copenhagen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Nutrition, Exercise and Sports, University of Copenhagen

City

Frederiksberg

ZIP/Postal Code

1958

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

31138673

Citation

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.

Results Reference

derived

PubMed Identifier

30827722

Citation

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.

Results Reference

derived

Links:

URL

http://www.mynewgut.eu/

Description

Project website

Learn more about this trial

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

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