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 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT02235805
Eligibility Criteria:
Inclusion Criteria:
* Aged between 45-70 years
* Women postmenopausal: two or more years after last menstruation
* BMI between 25-35 kg/m2 (overweight and slightly obese)
* Plasma glucose \< 7.0 mmol/L
* Serum total cholesterol \< 8.0 mmol/L
* Serum triacylglycerol \< 4.5 mmol/L
* No current smoker
* No diabetic patients
* No familial hypercholesterolemia
* No abuse of drugs
* Less than 21 alcoholic consumptions per week
* Stable body weight (weight gain or loss \< 3 kg in the past three months)
* No use of proton pump inhibitors or medication known to treat blood pressure, serum lipid or glucose metabolism
* No use of dietary supplements or an investigational product within another biomedical within the previous 1-month
* No 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
* No active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebro vascular accident
* Willingness to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study and during the study
* No difficult venipuncture as evidenced during the screening visit
Exclusion Criteria:
* High habitual dietary magnesium intake
* Plasma glucose ≥ 7.0 mmol/L
* Serum total cholesterol ≥ 8.0 mmol/L
* Serum triacylglycerol ≥ 4.5 mmol/L
* Current smoker, or smoking cessation \< 12 months
* Diabetic patients
* Familial hypercholesterolemia
* Abuse of drugs
* More than 21 alcoholic consumptions per week
* Unstable body weight (weight gain or loss \> 3 kg in the past three months)
* Use of proton pump inhibitors or medication known to treat blood pressure, serum lipid or glucose metabolism
* Use of dietary supplements or an investigational product within another biomedical 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 cerebro vascular accident
* Not willing to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study and during the study
* Not or difficult to venipuncture as evidenced during the screening visit
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
70 Years
Study:
NCT02235805
Study Brief:
Protocol Section:
NCT02235805