Status:
COMPLETED
Effect of Prebiotic and PUFA on the Gut Microbiota and Metabolic Risk Markers
Lead Sponsor:
University of Copenhagen
Collaborating Sponsors:
http://mynewgut.eu/partners
Conditions:
Overweight
Eligibility:
All Genders
18-60 years
Phase:
NA
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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02215343
Start Date
August 1 2014
End Date
June 1 2015
Last Update
May 20 2020
Active Locations (1)
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1
Department of Nutrition, Exercise and Sports, University of Copenhagen
Frederiksberg, Denmark, 1958