Overweight
Conditions
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.
Interventions
DIETARY_SUPPLEMENTWheat bran extract
Patients will be provided with 15g of wheat bran extract (WBE) (Cargill R&D Centre Europe).
DIETARY_SUPPLEMENTFish oil
Patients will be provided with a fish oil supplement (capsules), containing 3-4g of N-3 fatty acids (Axellus A/S, Ishøj, Denmark).
Sponsors
http://mynewgut.eu/partners
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in gut microbiota composition | Week 0, 4, 8, 12 | Gut microbiota composition will be analyzed by use of fecal samples. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in markers for inflammation | Week 0, 4, 8, 12 | Will be measured by use of fasting blood samples |
| Faecal SCFA and bile acid composition | Week 0, 4, 8, 12 | Will be analyzed by use of fecal 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. |
| Change in markers for insulin sensitivity | Week 0, 4, 8, 12 | Will be measured by use of fasting blood samples |
| Change in markers for lipid metabolism | Week 0, 4, 8, 12 | Will be measured by use of fasting blood samples |
Other
| Measure | Time frame | Description |
|---|---|---|
| Compliances markers | Week 0, 4, 8, 12 | 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 |
| Change in energy expenditure | Week 0, 4, 8, 12 | Resting energy expenditure will be measured by indirect calorimetry in a ventilated hood system |
| Gene expression | Week 0, 4, 8, 12 | Adipose tissue biopsies will be used for epigenetic analyses, gene and protein expression (no whole genome or exome sequencing). |
Countries
Denmark
Outcome results
None listed