Journal Article

Effects of magnesium citrate, magnesium oxide and magnesium sulfate supplementation on arterial stiffness in healthy overweight individuals: a study protocol for a randomized controlled trial

Schutten, Joëlle C., Goorman, Frans, Danel, Richard M., Bakker, Stephan J. L., Keyzer, Charlotte A., Joris, Peter J., Weersma, Rinse K., de Borst, Martin H., Heiner-Fokkema, M. Rebecca, Mensink, Ronald P.

2019

Overview

Background Arterial stiffness is closely related to the process of atherosclerosis, an independent cardiovascular risk factor, and predictive of future cardiovascular events and mortality. Recently, we showed that magnesium citrate supplementation results in a clinically relevant improvement of arterial stiffness. It remained unclear whether the observed effect was due to magnesium or citrate, and whether other magnesium compounds may have similar effects. Therefore, we aim to study the long-term effects of magnesium citrate, magnesium oxide and magnesium sulfate on arterial stiffness. In addition, we aim to investigate possible underlying mechanisms, including changes in blood pressure and changes in gut microbiota diversity. Methods In this randomized, double-blind, placebo-controlled trial, a total of 162 healthy overweight and slightly obese men and women will be recruited. During a 24-week intervention, individuals will be randomized to receive: magnesium citrate; magnesium oxide; magnesium sulfate (total daily dose of magnesium for each active treatment 450 mg); or placebo. The primary outcome of the study is arterial stiffness measured by the carotid–femoral pulse wave velocity (PWV c–f ), which is the gold standard for quantifying arterial stiffness. Secondary outcomes are office blood pressure, measured by a continuous blood pressure monitoring device, and gut microbiota, measured in fecal samples. Measurements will be performed at baseline and at weeks 2, 12 and 24. Discussion The present study is expected to provide evidence for the effects of different available magnesium formulations (organic and inorganic) on well-established cardiovascular risk markers, including arterial stiffness and blood pressure, as well as on the human gut microbiota. As such, the study may contribute to the primary prevention of cardiovascular disease in slightly obese, but otherwise healthy, individuals. Trial registration ClinicalTrials.gov, NCT03632590 . Retrospectively registered on 15 August 2018.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Aged / Analysis / Arterial stiffness / Atherosclerosis / Biomedicine / Blood & organ donations / Blood pressure / Blood Pressure - drug effects / Blood pressure measurement / Cardiovascular diseases / Citric Acid - administration & dosage / Clinical trials / Dietary Supplements / Disease / Double-Blind Method / Drug dosages / Gastrointestinal Microbiome - drug effects / Gut microbiota / Health aspects / Health Sciences / Humans / Intervention / Laboratories / Magnesium citrate / Magnesium compounds / Magnesium Compounds - administration & dosage / Magnesium Compounds - pharmacology / Magnesium oxide / Magnesium Oxide - administration & dosage / Magnesium sulfate / Magnesium Sulfate - administration & dosage / Magnesium supplements / Medicine / Medicine & Public Health / Metabolism / Metabolites / Microbiota / Microbiota (Symbiotic organisms) / Middle Aged / Mortality / Obesity / Organometallic Compounds - administration & dosage / Outcome Assessment, Health Care / Overweight / Overweight - physiopathology / Overweight persons / Patient monitoring equipment / Questionnaires / Randomized controlled trial / Randomized Controlled Trials as Topic / Statistics for Life Sciences / Study Protocol / Sulfates / Vascular Stiffness - drug effects