Soy Protein Intake and the Metabolic Syndrome
Λέξεις-κλειδιά
Αφηρημένη
Περιγραφή
Objective: The primary objective of the present study is to evaluate the effect of a high soy protein diet on insulin resistance and glycemic control in participants with characteristics of the metabolic syndrome. Secondly, the present study will evaluate whether reduced low-grade inflammation is a possible mechanism underlying the improvement in insulin resistance and glucose homeostasis. Finally, it will be assessed whether soy protein has beneficial effects on components of the metabolic syndrome, such as cardio-metabolic risk factors, blood lipid profile, blood pressure and endothelial function, fat storage in the liver and gene-expression in subcutaneous abdominal adipose tissue.
Study design: Single-blind, cross-over strictly-controlled dietary intervention.
Ημερομηνίες
| Τελευταία επαλήθευση: | 12/31/2012 |
| Πρώτα υποβλήθηκε: | 09/03/2012 |
| Υποβλήθηκε εκτιμώμενη εγγραφή: | 09/23/2012 |
| Δημοσιεύτηκε για πρώτη φορά: | 09/25/2012 |
| Υποβλήθηκε τελευταία ενημέρωση: | 01/02/2013 |
| Δημοσιεύτηκε η τελευταία ενημέρωση: | 01/03/2013 |
| Ημερομηνία έναρξης της πραγματικής μελέτης: | 08/31/2012 |
| Εκτιμώμενη κύρια ημερομηνία ολοκλήρωσης: | 11/30/2012 |
| Εκτιμώμενη ημερομηνία ολοκλήρωσης μελέτης: | 11/30/2012 |
Κατάσταση ή ασθένεια
Παρέμβαση / θεραπεία
Other: Soy protein diet
Other: Control diet
Φάση
Ομάδες βραχιόνων
| Μπράτσο | Παρέμβαση / θεραπεία |
|---|---|
| Experimental: Soy protein diet High mixed protein diet (20 en%) with 25gr of soy protein per day | Other: Soy protein diet 4 weeks high protein diet (20 en%) with 25gr of soy protein per day |
| Active Comparator: Control diet High mixed protein diet (20 en%) | Other: Control diet 4 weeks high mixed protein diet (20 en%) |
Κριτήρια καταλληλότητας
| Επιλέξιμες ηλικίες για μελέτη | 45 Years Προς την 45 Years |
| Φύλα επιλέξιμα για μελέτη | Female |
| Δέχεται υγιείς εθελοντές | Ναί |
| Κριτήρια | Inclusion Criteria: - Women - 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 - 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 blood pressure ≥135 mmHg or diastolic BP ≥85 mmHg or use of blood pressure lowering medication - Raised fasting plasma glucose ≥ 5.6 mmol/L 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 - Active or a history of thyroid disease - 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 (statins) - anti-conceptive use (such as the pill or IUD) - hormone replacement therapy - long-term antibiotics use - Habitual intake of soy foods (>1 soy food per week) - Isoflavone supplements - Vegetarian - Following, or have recently followed a (weight-loss) diet - Allergic to soy or dairy products - Smoking - Consuming more than 14 glasses of alcohol per week - Donated or intended to donate blood 2 months before till two months after the study - 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 |
Αποτέλεσμα
Πρωτεύοντα αποτελέσματα
1. Insulin sensitivity [4 weeks]
Δευτερεύοντα αποτελέσματα
1. Adipose tissue gene expression [4 weeks]
2. Blood lipids [4 weeks]
3. Inflammation markers and adipokines [4 weeks]
4. Cardio-metabolic risk factors [4 weeks]
5. Hepatic lipid content [4 weeks]
