Soy and Brain Vascular Function

Maastricht University Medical Centre (MUMC)

Status

Completed

Conditions

Brain Vascular Function

Cerebral Blood Flow

Cognitive Performance

Glucose Metabolism

Treatments

Dietary Supplement: Soy nuts

Study type

Interventional

Funder types

Other

Identifiers

NCT03627637

METC183017

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

60 to 70 years old

Volunteers

Accepts Healthy Volunteers

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
Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
Contra-indications for MRI imaging (e.g. pacemaker, surgical clips/material in body, metal splinter in eye, claustrophobia)