Magnesium and Vascular Stiffness

August 13, 2018 updated by: Stephan J.L. Bakker, University Medical Center Groningen

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

162

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Recruiting
        • University Medical Center Groningen
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged between 45-70 years
  • Women postmenopausal: two or more years after last menstruation
  • BMI between 25-35 kg/m2 (overweight and slightly obese)
  • Plasma glucose < 7.0 mmol/L
  • Serum total cholesterol < 8.0 mmol/L (further testing is recommended for excessive hyperlipidemia (serum total cholesterol ≥ 8.0 mmol/L) according to the Standard for cardiovascular risk management of the Dutch general practitioners community (NHG))
  • Serum triacylglycerol < 4.5 mmol/L (Friedewald formula)
  • No current smoker
  • No diabetic patients
  • No familial hypercholesterolemia
  • No abuse of drugs
  • Less than 21 alcoholic consumptions per week
  • Stable body weight (weight gain or loss <3 kg in the past three months)
  • No use of proton pump inhibitors
  • No use of magnesium supplements
  • No severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
  • No active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebro vascular accident
  • Willingness to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study and during the study
  • No difficult venipuncture as evidenced during the screening visit
  • Written informed consent

Exclusion Criteria:

  • High habitual dietary magnesium intake (defined as urinary magnesium excretion of 7.0 or 5.9 mmol/24-h or more for men and women, respectively)
  • Plasma glucose ≥ 7.0 mmol/L
  • Serum total cholesterol ≥ 8.0 mmol/L
  • Serum triacylglycerol ≥ 4.5 mmol/L
  • Current smoker, or smoking cessation <12 months
  • Diabetic patients
  • Familial hypercholesterolemia
  • Abuse of drugs
  • More than 21 alcoholic consumptions per week
  • Unstable body weight (weight gain or loss > 3 kg in the past three months)
  • Use of proton pump inhibitors
  • Use of magnesium supplements
  • Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
  • Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebro vascular accident
  • Not willing to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study and during the study
  • Not or difficult to venipuncture as evidenced during the screening visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
The placebo capsules will contain starch (Amylum solani) for 24 weeks
Experimental: Magnesium Citrate
450 mg of Magnesium Citrate per day
Dietary supplement: Magnesium Citrate
450 mg of Magnesium Citrate per day (6 capsules per day) for 24 weeks
Experimental: Magnesium Sulfate
450 mg of Magnesium Sulfate per day
Dietary supplement: Magnesium Sulfate
450 mg of Magnesium Sulfate per day (6 capsules per day) for 24 weeks
Experimental: Magnesium Oxide
450 mg of Magnesium Oxide per day
Dietary supplement: Magnesium Oxide
450 mg of Magnesium Oxide per day (6 capsules per day) for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in vascular stiffness
Time Frame: Baseline, FU-1 (2 weeks), FU-2 (12 weeks), and FU-3 (24 weeks)
Measured from carotid-femoral pulse wave velocity (PWV). For this assessment, a SphygmoCor will be used (SphygmoCor v9, AtCor Medical).
Baseline, FU-1 (2 weeks), FU-2 (12 weeks), and FU-3 (24 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in blood pressure
Time Frame: Baseline, FU-1 (2 weeks), FU-2 (12 weeks), and FU-3 (24 weeks)
Measured from a semi continuous blood pressure monitoring device
Baseline, FU-1 (2 weeks), FU-2 (12 weeks), and FU-3 (24 weeks)
Change in gut microbiota
Time Frame: Baseline, FU-1 (2 weeks), FU-2 (12 weeks), and FU-3 (24 weeks)
Measured from fecal samples
Baseline, FU-1 (2 weeks), FU-2 (12 weeks), and FU-3 (24 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Collaborators

Nedmag Industries Mining and Manufacturing B.V.

Investigators

  • Principal Investigator: Stephan JL Bakker, MD-PhD, University Medical Center Groningen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2018

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

August 6, 2018

First Submitted That Met QC Criteria

August 13, 2018

First Posted (Actual)

August 15, 2018

Study Record Updates

Last Update Posted (Actual)

August 15, 2018

Last Update Submitted That Met QC Criteria

August 13, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METc2017/220

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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