Magnesium and Vascular Stiffness

Maastricht University Medical Centre (MUMC)

Status

Completed

Conditions

Obesity

Metabolic Syndrome

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Magnesium Citrate

Study type

Interventional

Funder types

Other

Identifiers

NCT02235805

MEC 14-3-021

Details and patient eligibility

About

Observational epidemiologic studies have observed an inverse relationship between daily dietary magnesium intake and blood pressure (BP). Except for BP, magnesium may also beneficially affect other cardiovascular risk markers. Whether all these effects translate into improved vascular function is not known. Different vascular function markers at various stages on the pathway between diet and disease exist. One of these markers, vascular stiffness, is closely related to the process of atherosclerosis, an independent cardiovascular risk factor, and predictive of future cardiovascular events and mortality. To examine the integrated effects of interventions on cardiovascular risk, vascular stiffness may therefore serve as a marker at the later stage of cardiovascular disease development.

Therefore, it is imperative to examine in a 24-week, randomized, double-blind, placebo-controlled, two-way parallel-group human intervention study, the effect of magnesium on vascular stiffness. Focus will be on carotid-femoral pulse wave velocity (PWV), the gold standard for the evaluation of vascular elasticity, to quantify vascular stiffness. Urinary excretion of magnesium will be used to assess dietary magnesium uptake. Furthermore, time courses of an increased magnesium intake on changes in BP, other markers reflecting vascular function, and plasma biomarkers related to low-grade inflammation and vascular activity will be measured to unravel possible cause-effect relationships.

Enrollment

52 patients

Sex

All

Ages

45 to 70 years old

Volunteers

Accepts Healthy Volunteers

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