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

Not Applicable

Completed

• Conditions: Overweight
• Interventions: Dietary Supplement: Fish oil; Dietary Supplement: Wheat bran extract

• Registration Number: NCT02215343
• Lead Sponsor: University of Copenhagen

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 available

Study Timeline

• Study First Submitted: 2014-07-15
• Study Start: 2014-08
• Study First Submitted QC: 2014-08-11
• Study First Posted: 2014-08-13
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-18
• Last Update Posted: 2020-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High PUFA diet (fish oil supplement)	Fish oil	-
High fibre diet (wheat bran extract)	Wheat bran extract	-

Primary Outcome Measures

Name	Time	Method
Change in gut microbiota composition	Week 0, 4, 8, 12	Gut microbiota composition will be analyzed by use of fecal samples.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Nutrition, Exercise and Sports, University of Copenhagen; 🇩🇰 Frederiksberg, Denmark