NCT03632590

Magnesium and Vascular Stiffness

The Effects of Magnesium Salts on Vascular Stiffness: A Randomized Controlled Trial in Healthy Overweight and Slightly Obese Men and Women

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 162 (estimated)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This four-arm randomized controlled trial was designed to study the effects of magnesium supplements (total daily dose: 450 mg elemental magnesium) on vascular stiffness in healthy overweight and slightly obese men and women. In addition, the effects of magnesium supplements on blood pressure and gut microbiota will be evaluated. Three groups will receive magnesium supplements (magnesium oxide, magnesium citrate or magnesium sulphate) and one group will receive a placebo.

Detailed description

Observational epidemiologic studies have observed an inverse relationship between daily dietary magnesium intake and blood pressure. Except for blood pressure, 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. A recently published intervention study showed that oral magnesium citrate supplementation of 350 mg per day for 24 weeks was well-tolerated and improved vascular stiffness by 1.0 m/s. Importantly, it was not established whether the beneficial effect on vascular stiffness was due to the supplementation of magnesium or due to citrate. This may involve effects on gut microbiota and systemic metabolic effects. The current study was designed to (1) reproduce the result of the earlier study and to (2) investigate whether there is a difference between different commonly used magnesium salts (magnesium citrate, magnesium sulphate and magnesium oxide) in terms of effects on vascular stiffness, blood pressure and gut microbiota.

Conditions

• Vascular Stiffness
• Blood Pressure

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Magnesium Citrate	450 mg of Magnesium Citrate per day (6 capsules per day) for 24 weeks
DIETARY_SUPPLEMENT	Magnesium Sulfate	450 mg of Magnesium Sulfate per day (6 capsules per day) for 24 weeks
DIETARY_SUPPLEMENT	Magnesium Oxide	450 mg of Magnesium Oxide per day (6 capsules per day) for 24 weeks
DRUG	Placebo	The placebo capsules will contain starch (Amylum solani) for 24 weeks

Timeline

• Start date: 2018-03-27
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2018-08-15
• Last updated: 2018-08-15

Locations

1 site across 1 country: Netherlands