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

University of Copenhagen

Status: Completed

Conditions: Overweight

Treatments: Dietary Supplement: Fish oil; Dietary Supplement: Wheat bran extract

Study type: Interventional

Funder types: Other

Identifiers

NCT02215343

MyNewGut, Task 3.3

Grant Agreement no: 613979 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

High fibre diet (wheat bran extract)

Experimental group

Treatment:

Dietary Supplement: Wheat bran extract

High PUFA diet (fish oil supplement)

Experimental group

Treatment:

Dietary Supplement: Fish oil