diabetes insuline sensitivity Metabolic syndrome
Conditions
Interventions
High mixed-protein diet or high soy protein diet for 4 weeks.
Sponsors
Wageningen Universiteit
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Women Central obesity: waist circumference >=80 cm plus any one of the following four factors: - Raised triglyceride level: >=1.7 mmol/L; - Reduced high-density lipoprotein (HDL) cholesterol: =135 mmHg or diastolic BP >=85 mmHg or use of blood pressure lowering medication - Raised fasting plasma glucose >= 5.6 mmol/L Additional inclusion criteria: 45-70 years No menstrual cycle for >=1 year Stable body weight for >=6 months (no weight gain/loss > 3 kg) Stable exercise habits during the last 6 months, and not participating in any vigorous exercise program
Exclusion criteria
Exclusion criteria: *(Undiagnosed) Diabetes - but not impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) as evaluated by an oral glucose tolerance test at screening *Active hearth disease, i.e. history of myocardial infarction, stroke or angina pectoris *A history of stroke, coronary heart diseases, thyroid disease, or breast, uterine or ovarian cancer, or other malignancies in the past 5 years *Two sided ovariectomy *Drug use knowing to interfere with objectives of the study - oral corticosteroids, lipid-lowering drugs (such as statins) - anti-conceptive use (such as the pill or IUD) - hormone replacement therapy - long-term antibiotics use - isoflavone supplements *Allergic to soy or dairy products *Vegetarian *Following, or have recently followed a (weight-loss) diet *Habitual intake of soy foods (>1 soy food per week) *Donated or intended to donate blood 2 months before till two months after the study *more than 7 alcoholconsumptions per week *Smoker *Participation in another biomedical study within 1 month before the first screening visit *Not willing to be informed if deviations are found in blood samples *Contraindications to MRI scanning
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters include insulin resistance and glycemic control, blood lipids, inflammation markers, adipokines, blood pressure and endothelial function. | — |
Secondary
| Measure | Time frame |
|---|---|
| secundary study parameters are changes fat storage in the liver, expression of genes involved in lipid handling in adipose tissue, and genes involved in lipid handling and inflammation as measured in PBMCs | — |
Countries
Netherlands
Outcome results
None listed