The impact of Central European diet on metabolic risk factors - a modern nutrition approach
- Conditions
- E66.0Obesity due to excess calories
- Registration Number
- DRKS00012958
- Lead Sponsor
- ational Science Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 144
Nonsmoking, postmenopausal women (with absence of of menses > 12 months or a serum follicle-stimulating hormone >30 IU/mL) with central obesity (waist circumference = 80 cm), plus at least one other criterion of metabolic syndrome
Women with type 2 diabetes, monogenic dyslipidemia, history of cardiovascular disease, using medications which may affect nutrient metabolism or absorption or any medications for psychiatric disorders or anti-inflammatory drugs, with endocrine disorders or on hormonal replacement therapy were not eligible. Exclusion criteria also included significantly weight changes in the six months prior to the current study, intolerance or food allergy to key components of the intervention diets, excessive alcohol consumption (>2 drinks/day).
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in body weight and body composition at baseline and after 4, 8, 12 and 16 weeks and after one year follow-up dietary trial. Changes in parameters for metabolic risk factors (waist circumference, glucose, insulin, total, LDL and HDL cholesterol triglyceride concentrations as well as blood pressure) at baseline and after 4, 8, 12 and 16 weeks and after one year follow-up dietary trial. Expression of IL-6 and TNF alpha in PBMC before and after dietary intervention. Genotyping to assess PPAR-y, FTO and IL-6 before dietary intervention. Adherance to prescribed diets using a 3-day food diary at baseline and after 4, 8, 12 and 16 weeks and after one year follow-up dietary trial. Changes in serum leptin, IL-6, TNFa, CRPhs, before and after dietary intervention.
- Secondary Outcome Measures
Name Time Method Changes in liver metabolism by the 13C-methacetin-breath test before and after dietary intervention. Changes in RMR and RQ parameters before, after dietary intervention and one year after follow-up. Changes in ADMA before and after dietary trial. Quantitative and qualitative assessment of the fatty acids profile in erythrocyte membranes by gas chromatography. Analyses of relationship between 3 factors: fatty acids intake, polymorphisms of selected genes involved in lipid metabolism (e.g. including FADS1 and FADS2 genetic variants on endogenous fatty acids metabolism) and blood lipids contentrations. Changes in CML concentrations in blood before and after dietary intervention. Changes in Ne-carboxymethyllysine (CML) concentrations in blood before and after dietary intervention