Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT04831203
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
75 Years
Study:
NCT04831203
Study Brief:
Protocol Section:
NCT04831203