Status:
COMPLETED
NWT-03 and Brain Function
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Brain Vascular Function
Cognition
Eligibility:
All Genders
60-75 years
Phase:
NA
Brief Summary
Age-related chronic diseases including dementia, type II diabetes mellitus (T2DM) and cardiovascular disease (CVD) become more prevalent and of increasing societal concern. Common denominators of thes...
Detailed Description
Due to the aging population, the number of people with cognitive impairment will have doubled by the year 2035. Also, the number of individuals with type-2 diabetes mellitus (T2DM) and cardiovascular ...
Eligibility Criteria
Inclusion
- Men and women, aged between 60-75 years
- Subjective cognitive decline (SCD)
- BMI between 25-35 kg/m2
- Fasting plasma glucose \< 7.0 mmol/L
- Fasting serum total cholesterol \< 8.0 mmol/L (further testing will be performed for excessive hyperlipidemia \[serum total cholesterol ≥ 8.0 mmol/L\] according to the Standard for cardiovascular risk management of NHG)
- 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
- Left-handedness
- Current smoker, or smoking cessation \< 12 months
- Diabetic patients
- Familial hypercholesterolemia
- Abuse of drugs
- More than 3 alcoholic units per day
- Use of vitamin or mineral supplements known to interfere with the main outcomes as judged by the principal investigators within the previous 1-month
- Use of medication to treat blood pressure, lipid or glucose metabolism
- Use of an investigational product within another 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)
Key Trial Info
Start Date :
April 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2022
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04831203
Start Date
April 23 2021
End Date
October 24 2022
Last Update
November 9 2022
Active Locations (1)
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1
Maastricht University
Maastricht, Limburg, Netherlands, 6211 LK