The Effects of Soy on Brain Vascular Function in Elderly Men and Women
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Brain Vascular Function
- Sponsor
- Maastricht University Medical Center
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Brain vascular function
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
Cognitive performance is negatively related to an impaired glucose metabolism, possibly due to impairments in brain vascular function. Supported by the statement from the American Heart and American Stroke Association that healthy plant-based diets, which consist of soy foods, protect against cognitive decline, we now hypothesize that soy-induced changes in glucose metabolism cause beneficial effects on brain vascular function thereby improving cognitive performance. The primary objective of this intervention study is thus to evaluate in elderly men and women the effect of a 16-week soy intervention on cerebral blood flow, as quantified by the non-invasive gold standard magnetic resonance imaging (MRI) perfusion method Arterial Spin Labeling (ASL). Cerebral blood flow is a robust and sensitive physiological marker of brain vascular function. Secondary objectives are to examine effects on glucose metabolism using the oral glucose tolerance test and cognitive performance as assessed with a neurophysiological test battery.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged between 60-70 years
- •BMI between 20-30 kg/m2
- •Fasting plasma glucose \< 7.0 mmol/L
- •Fasting serum total cholesterol \< 8.0 mmol/L
- •Fasting serum triacylglycerol \< 4.5 mmol/L
- •Systolic blood pressure \< 160 mmHg and diastolic blood pressure \< 100 mmHg
- •Stable body weight (weight gain or loss \< 3 kg in the past three months)
- •Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study
- •No difficult venipuncture as evidenced during the screening visit
Exclusion Criteria
- •Allergy or intolerance to soy
- •Current smoker, or smoking cessation \< 12 months
- •Diabetic patients
- •Familial hypercholesterolemia
- •Abuse of drugs
- •More than 3 alcoholic consumptions per day
- •Use of soy products or dietary supplements known to interfere with the main outcomes as judged by the principal investigators
- •Use medication to treat blood pressure, lipid or glucose metabolism
- •Use of an investigational product within another biomedical intervention trial within the previous 1-month
- •Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
Outcomes
Primary Outcomes
Brain vascular function
Time Frame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Cerebral blood flow as quantified non-invasively by the MRI perfusion method Arterial Spin Labeling (ASL)
Secondary Outcomes
- Glucose metabolism(Difference between outcomes at the end of a 16-week soy nut intervention and control period.)
- Cognitive performance(Difference between outcomes at the end of a 16-week soy nut intervention and control period.)