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Vascular StiffnessNCT03632590

Magnesium and Vascular Stiffness

A study testing Magnesium Citrate, Magnesium Sulfate and Magnesium Oxide in people with Vascular Stiffness and Blood Pressure, run by University Medical Center Groningen at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Vascular Stiffness, Blood Pressure
What is being tested?
Magnesium Citrate, Magnesium Sulfate and Magnesium Oxide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
162 participants
Where
1 siteNetherlands
Study dates
27 Mar 2018to Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Joëlle C Schutten, MSc contact

+31 50 3612679

j.c.schutten@umcg.nl

Netherlands1 site, 1 recruiting

  • University Medical Center Groningen

    Groningen, 9713 GZ

    Joëlle C Schutten, MSc, +31 50 3612679, j.c.schutten@umcg.nl

    Stephan JL Bakker, MD-PhD, +31 50 3613677, s.j.l.bakker@umcg.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: 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.

Read the 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.

Being tested
Magnesium Citrate, Magnesium Sulfate, Magnesium Oxide, Placebo
Keywords
Magnesium, Supplements

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnesium CitrateDietary supplement

    450 mg of Magnesium Citrate per day (6 capsules per day) for 24 weeks

  • Magnesium SulfateDietary supplement

    450 mg of Magnesium Sulfate per day (6 capsules per day) for 24 weeks

  • Magnesium OxideDietary supplement

    450 mg of Magnesium Oxide per day (6 capsules per day) for 24 weeks

  • PlaceboDrug

    The placebo capsules will contain starch (Amylum solani) for 24 weeks

Study groups in NCT03632590
Study groupRoleWhat they receive
Magnesium CitrateExperimental450 mg of Magnesium Citrate per day
Receives: Dietary Supplement: Magnesium Citrate
Magnesium SulfateExperimental450 mg of Magnesium Sulfate per day
Receives: Dietary Supplement: Magnesium Sulfate
Magnesium OxideExperimental450 mg of Magnesium Oxide per day
Receives: Dietary Supplement: Magnesium Oxide
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in vascular stiffness

    Measured from carotid-femoral pulse wave velocity (PWV). For this assessment, a SphygmoCor will be used (SphygmoCor v9, AtCor Medical).

    Measured: Baseline, FU-1 (2 weeks), FU-2 (12 weeks), and FU-3 (24 weeks)

Secondary outcomes (2)

  1. Change in blood pressure

    Measured from a semi continuous blood pressure monitoring device

    Measured: Baseline, FU-1 (2 weeks), FU-2 (12 weeks), and FU-3 (24 weeks)

  2. Change in gut microbiota

    Measured from fecal samples

    Measured: Baseline, FU-1 (2 weeks), FU-2 (12 weeks), and FU-3 (24 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2018
  2. Study start27 Mar 2018
  3. Primary completionJan 2020 (estimated)
  4. Study completionJan 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
162 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03632590
Sponsor's protocol ID
METc2017/220
Status last verified
Aug 2018
First submitted
6 Aug 2018
Last updated
15 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Schutten JC, Joris PJ, Groendijk I, Eelderink C, Groothof D, van der Veen Y, Westerhuis R, Goorman F, Danel RM, de Borst MH, Bakker SJL. Effects of Magnesium Citrate, Magnesium Oxide, and Magnesium Sulfate Supplementation on Arterial Stiffness: A Randomized, Double-Blind, Placebo-Controlled Intervention Trial. J Am Heart Assoc. 2022 Mar 15;11(6):e021783. doi: 10.1161/JAHA.121.021783. Epub 2022 Mar 5.

    PubMed 35253448

  • Schutten JC, Joris PJ, Mensink RP, Danel RM, Goorman F, Heiner-Fokkema MR, Weersma RK, Keyzer CA, de Borst MH, Bakker SJL. 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. Trials. 2019 May 28;20(1):295. doi: 10.1186/s13063-019-3414-4.

    PubMed 31138315

Questions about this trial

What is this clinical trial studying?

A study testing Magnesium Citrate, Magnesium Sulfate and Magnesium Oxide in people with Vascular Stiffness and Blood Pressure, run by University Medical Center Groningen at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Joëlle C Schutten, MSc (+31 50 3612679, j.c.schutten@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in vascular stiffness (time frame: Baseline, FU-1 (2 weeks), FU-2 (12 weeks), and FU-3 (24 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03632590, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2018.

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