The effects of soy on brain vascular function in elderly men and wome

Completed

• Conditions: Insulin Resistance Syndrome; Metabolic Syndrome; Syndrome X; 10018424

• Registration Number: NL-OMON45812
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-12-23
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 25

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>At baseline, anthropometric measurements will be first performed and a fasting<br /><br>blood sample will be drawn. After sixteen weeks, adults have to attend two<br /><br>times the research facilities to perform follow-up measurements. The primary<br /><br>endpoint is the difference at follow-up in mean gray matter cerebral blood<br /><br>flow, as assessed by Arterial Spin Labeling, between the soy and control<br /><br>treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable.</p><br>