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ong-term effects of mixed nuts consumption on brain vascular function in elderly men and women.

Completed
Conditions
Insulin Resistance Syndrome
Metabolic Syndrome
Syndrome X
10018424
Registration Number
NL-OMON48256
Lead Sponsor
niversiteit Maastricht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
30
Inclusion Criteria

- Aged between 60-70 years
- BMI between 25-35 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 nuts
- Left handedness
- Current smoker, or smoking cessation < 12 months
- Diabetic patients
- Familial hypercholesterolemia
- Abuse of drugs
- More than 3 alcoholic consumptions per day
- Use of nuts 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
NameTimeMethod
<p>At baseline, first anthropometric measurements will be performed and blood<br /><br>pressure will be determined. In addition, a fasting blood sample will be drawn.<br /><br>Another fasting blood sample will be draw at eight weeks, while participants<br /><br>have to attend the research facilities two times to perform follow-up<br /><br>measurements after sixteen weeks. The primary endpoint is the difference at<br /><br>follow-up in cerebral blood flow, as assessed by ASL, between interventions.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary endpoints are the cerebral blood flow response to intranasal insulin<br /><br>delivery as quantified by ASL, and cognitive functioning as assessed with a<br /><br>neuropsychological test battery.</p><br>
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