Insulin Resistance Syndrome Metabolic Syndrome Syndrome X
Conditions
Interventions
After the first test day, the overweight and slightly obese subjects will be
randomly assigned to receive magnesium citrate or a placebo for 24 weeks.
Subjects assigned to the oral magnesium treatm
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion 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
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the difference in response on vascular stiffness measured from carotid-femoral PWV: Between overweight and slightly obese participants that received magnesium citrate (total daily dose: 350 mg elemental magnesium) or a placebo for 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are effects and changes over time of an increased magnesium intake on BP, other markers reflecting vascular function (e.g. pulse wave analysis (PWA), flow-mediated dilation (FMD), finger peripheral arterial tonometry (PAT) and microvascular diameters), and plasma biomarkers related to low-grade inflammation and vascular activity. | — |
Countries
Netherlands
Outcome results
None listed