Cognitive Performance Clinical Trial
Official title:
The Effects of Soy on Brain Vascular Function in Elderly Men and Women
Verified date | January 2020 |
Source | Maastricht University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 23 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years to 70 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Netherlands | Maastricht University Medical Center | Maastricht | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center | Alpro Foundation |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Other physiological parameters: Peripheral vascular function (1) | Flow-mediated vasodilation (FMD) | Difference between outcomes at the end of a 16-week soy nut intervention and control period. | |
Other | Other physiological parameters: Peripheral vascular function (2) | Carotid artery reactivity (CAR) | Difference between outcomes at the end of a 16-week soy nut intervention and control period. | |
Other | Other physiological parameters: Peripheral vascular function (3) | Pulse wave analysis (PWA) | Difference between outcomes at the end of a 16-week soy nut intervention and control period. | |
Other | Other physiological parameters: Peripheral vascular function (4) | pulse wave velocity (PWV) | Difference between outcomes at the end of a 16-week soy nut intervention and control period. | |
Other | Other physiological parameters: Peripheral vascular function (5) | Retinal images | Difference between outcomes at the end of a 16-week soy nut intervention and control period. | |
Other | Other physiological parameters: Blood pressure | Office and 24-hour ambulatory blood pressure | Difference between outcomes at the end of a 16-week soy nut intervention and control period. | |
Other | Other physiological parameters: Continuous blood glucose | 36-hour glycaemic response | Difference between outcomes at the end of a 16-week soy nut intervention and control period. | |
Other | Other physiological parameters: Advanced glycation endproducts | Serum protein-bound advanced glycation endproducts (AGEs) | Difference between outcomes at the end of a 16-week soy nut intervention and control period. | |
Other | Other physiological parameters: Conventional metabolic risk markers (1) | Lipids and Lipoproteins | Difference between outcomes at the end of a 16-week soy nut intervention and control period. | |
Other | Other physiological parameters: Conventional metabolic risk markers (2) | Glucose | Difference between outcomes at the end of a 16-week soy nut intervention and control period. | |
Other | Other physiological parameters: Conventional metabolic risk markers (3) | Insulin | Difference between outcomes at the end of a 16-week soy nut intervention and control period. | |
Other | Other physiological parameters: Conventional metabolic risk markers (4) | Markers for low-grade systemic inflammation | Difference between outcomes at the end of a 16-week soy nut intervention and control period. | |
Other | Other physiological parameters: Conventional metabolic risk markers (5) | Markers for microvascular function | Difference between outcomes at the end of a 16-week soy nut intervention and control period. | |
Other | Other physiological parameters: Other parameters (1) | Brain-derived neurotrophic factor (blood) | Difference between outcomes at the end of a 16-week soy nut intervention and control period. | |
Other | Other physiological parameters: Other parameters (2) | Cortisol levels (saliva) | Difference between outcomes at the end of a 16-week soy nut intervention and control period. | |
Other | Other physiological parameters: Parameters for compliance | Isoflavone levels (urine and blood) | Difference between outcomes at the end of a 16-week soy nut intervention and control period. | |
Other | Other perceivable benefits: Quality of Life | The Quality of life (QoL) will be assessed using a 32-item questionnaire | Difference between outcomes at the end of a 16-week soy nut intervention and control period. | |
Other | Other perceivable benefits: Sleep characteristics | Sleep characteristics will be assessed using the 10-item Pittsburgh Sleep Quality Index | Difference between outcomes at the end of a 16-week soy nut intervention and control period. | |
Other | Other perceivable benefits: Mood | Mood will be tested using the Affect Grid | Difference between outcomes at the end of a 16-week soy nut intervention and control period. | |
Other | Other perceivable benefits: Physical fitness (1) | Timed up-and-go test (TUGT) | Difference between outcomes at the end of a 16-week soy nut intervention and control period. | |
Other | Other perceivable benefits: Physical fitness (2) | The 6-minute walk test (6 MWT) | Difference between outcomes at the end of a 16-week soy nut intervention and control period. | |
Other | Other perceivable benefits: Physical fitness (3) | Handgrip test | Difference between outcomes at the end of a 16-week soy nut intervention and control period. | |
Other | Other perceivable benefits: Physical fitness (4) | Muscle strength test | Difference between outcomes at the end of a 16-week soy nut intervention and control period. | |
Primary | Brain vascular function | Cerebral blood flow as quantified non-invasively by the MRI perfusion method Arterial Spin Labeling (ASL) | Difference between outcomes at the end of a 16-week soy nut intervention and control period. | |
Secondary | Glucose metabolism | Oral Glucose Tolerance Test (OGTT) | Difference between outcomes at the end of a 16-week soy nut intervention and control period. | |
Secondary | Cognitive performance | Cambridge Neuropsychological Test Automated Battery (CANTAB) | Difference between outcomes at the end of a 16-week soy nut intervention and control period. |
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