Soy protein intake and the metabolic syndrome, reducing inflammation to improve insulin resistance and glucose homeostasis

Completed

• Conditions: diabetes; insuline sensitivity; Metabolic syndrome; 10018424

• Registration Number: NL-OMON37857
• Lead Sponsor: Wageningen Universiteit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

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: <1.29 mmol/L
- Raised blood pressure: systolic BP >=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

*(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

Study & Design

• Study Type: Interventional
• Study Design: Not specified