Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Top Institute Food and Nutrition | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnesium Citrate | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Citrate | Dietary Supplement | One capsule thrice daily that contains magnesium citrate (total daily dose: 350 mg elemental magnesium) at breakfast, lunch and dinner for 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Vascular stiffness: effects of magnesium citrate supplementation | Carotid-femoral pulse wave velocity (PWV) | Baseline (0 weeks) and after medium-term (12 weeks) and long-term (24 weeks) magnesium citrate supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| Vascular function markers: effects of magnesium citrate supplementation | Flow-mediated dilation (FMD) of the brachial artery, pulse wave analysis (PWA) (also at 12 weeks), peripheral arterial tonometry (PAT) and retinal microvascular diameters (also at 12 weeks) | Baseline (0 weeks) and after long-term (24 weeks) magnesium citrate supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary magnesium uptake | 24-hour urine samples | Baseline (0 weeks) and after long-term (24 weeks) magnesium citrate supplementation |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ronald P Mensink, PhD | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center | Maastricht | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33030273 | Derived | Schutten JC, Joris PJ, Minovic I, Post A, van Beek AP, de Borst MH, Mensink RP, Bakker SJL. Long-term magnesium supplementation improves glucocorticoid metabolism: A post-hoc analysis of an intervention trial. Clin Endocrinol (Oxf). 2021 Feb;94(2):150-157. doi: 10.1111/cen.14350. Epub 2020 Oct 26. | |
| 27053384 | Derived |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C110422 | magnesium citrate |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Dietary Supplement | One capsule thrice daily that contains placebo at breakfast, lunch and dinner for 24 weeks |
|
| Metabolic risk markers related to the metabolic syndrome: effects of magnesium citrate supplementation | Biomarkers for low-grade inflammation and endothelial activation | Baseline (0 weeks) and after medium-term (12 weeks) and long-term (24 weeks) magnesium citrate supplementation |
| Blood pressure: effects of magnesium citrate supplementation | Office (also at 12 weeks) and 24-hour ambulatory blood pressure | Baseline (0 weeks) and after long-term (24 weeks) magnesium citrate supplementation |
| Joris PJ, Plat J, Bakker SJ, Mensink RP. Long-term magnesium supplementation improves arterial stiffness in overweight and obese adults: results of a randomized, double-blind, placebo-controlled intervention trial. Am J Clin Nutr. 2016 May;103(5):1260-6. doi: 10.3945/ajcn.116.131466. Epub 2016 Apr 6. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |