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:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2025-12-25 @ 3:02 AM
NCT ID:
NCT05268133
Eligibility Criteria:
Inclusion Criteria:
* Men and women, aged between 55-75 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:
* Smoking or smoking cessation \< 12 months
* Presence of diabetes mellitus
* Active cardiovascular disease like congestive heart failure or cardiovascular event
* Severe medical conditions, including asthma, chronic obstructive pulmonary disease (COPD), kidney failure, auto-inflammatory diseases or rheumatoid arthritis
* Unstable body weight (weight gain or loss \> 3 kg in the past three months)
* Use of dietary supplements or medication affecting the main outcomes of the study
* Use of an investigational product within another biomedical intervention trial within the previous month
* Contra-indications for MRI imaging (e.g., pacemaker, surgical clips/material in body, metal splinter in eye, claustrophobia)
* Left-handedness
* Familial hypercholesterolemia
* Abuse of drugs
* More than 3 alcoholic consumptions per day
* Use medication to treat blood pressure, lipid or glucose metabolism
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
75 Years
Study:
NCT05268133
Study Brief:
Protocol Section:
NCT05268133