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

Overweight Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02215343
• Other study ID #: MyNewGut, Task 3.3
• Secondary ID: Grant Agreement
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: June 2015

Study information

• Verified date: May 2020
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Nutrition, Exercise and Sports, University of Copenhagen	Frederiksberg

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	http://mynewgut.eu/partners

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in energy expenditure	Resting energy expenditure will be measured by indirect calorimetry in a ventilated hood system	Week 0, 4, 8, 12
Other	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
Other	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
Primary	Change in gut microbiota composition	Gut microbiota composition will be analyzed by use of fecal samples.	Week 0, 4, 8, 12
Secondary	Change in markers for insulin sensitivity	Will be measured by use of fasting blood samples	Week 0, 4, 8, 12
Secondary	Change in markers for lipid metabolism	Will be measured by use of fasting blood samples	Week 0, 4, 8, 12
Secondary	Change in markers for inflammation	Will be measured by use of fasting blood samples	Week 0, 4, 8, 12
Secondary	Faecal SCFA and bile acid composition	Will be analyzed by use of fecal samples.	Week 0, 4, 8, 12
Secondary	Lipidomics	Will be analyzed by use of fasting blood samples and fecal samples.	Week 0, 4, 8, 12
Secondary	Metabolomics	Will be analyzed by use of fasting blood samples, urine and fecal samples.	Week 0, 4, 8, 12

External Links

•   Project website