TY - JOUR
T1 - Effects of magnesium citrate, magnesium oxide and magnesium sulfate supplementation on arterial stiffness in healthy overweight individuals
T2 - a study protocol for a randomized controlled trial
AU - Schutten, Joelle C.
AU - Joris, Peter J.
AU - Mensink, Ronald P.
AU - Danel, Richard M.
AU - Goorman, Frans
AU - Heiner-Fokkema, M. Rebecca
AU - Weersma, Rinse K.
AU - Keyzer, Charlotte A.
AU - de Borst, Martin H.
AU - Bakker, Stephan J. L.
N1 - Funding Information:
The project is supported by funding from the Nedmag Industries Mining en Manufacturing BV (NIMM) and the NIGRAM2+ collaboration project, financed by the PPP Allowance made available by Top Sector Life Sciences & Health to the Dutch Kidney Foundation to stimulate public–private partnerships. The NIMM and the NIGRAM2+ collaboration project did not have any role in study design and data collection, and will not have a role in analysis, interpretation or drafting the final reports of the study.
Publisher Copyright:
© 2019 The Author(s).
PY - 2019/5/28
Y1 - 2019/5/28
N2 - BackgroundArterial 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.MethodsIn 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 450mg); or placebo. The primary outcome of the study is arterial stiffness measured by the carotid-femoral pulse wave velocity (PWVc-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.DiscussionThe 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 registrationClinicalTrials.gov, NCT03632590. Retrospectively registered on 15 August 2018.
AB - BackgroundArterial 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.MethodsIn 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 450mg); or placebo. The primary outcome of the study is arterial stiffness measured by the carotid-femoral pulse wave velocity (PWVc-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.DiscussionThe 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 registrationClinicalTrials.gov, NCT03632590. Retrospectively registered on 15 August 2018.
KW - Magnesium supplements
KW - Arterial stiffness
KW - Blood pressure
KW - Gut microbiota
KW - Randomized controlled trial
KW - GUT MICROBIOTA
KW - BLOOD-PRESSURE
KW - DOUBLE-BLIND
KW - CARDIOVASCULAR EVENTS
KW - ENDOTHELIAL FUNCTION
KW - RISK
KW - ATHEROSCLEROSIS
KW - METABOLISM
KW - URINARY
KW - YOUNG
U2 - 10.1186/s13063-019-3414-4
DO - 10.1186/s13063-019-3414-4
M3 - Article
C2 - 31138315
SN - 1745-6215
VL - 20
SP - 1
EP - 8
JO - Trials
JF - Trials
M1 - 295
ER -