Obesity Clinical Trial
Official title:
The Effects of Magnesium on Vascular Stiffness: A Long-term Study in Healthy Overweight and Slightly Obese Men and Women
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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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