Metabolic SyndromeNCT02235805
Magnesium and Vascular Stiffness
A study testing Magnesium Citrate in people with Metabolic Syndrome and Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Observational epidemiologic studies have observed an inverse relationship between daily dietary magnesium intake and blood pressure (BP). Except for BP, magnesium may also beneficially affect other cardiovascular risk markers. Whether all these effects translate into improved vascular function is not known. Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Obesity
- What is being tested?
- Magnesium Citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2014to Sep 2015
- 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 70 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
- Serum triacylglycerol < 4.5 mmol/L
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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 or medication known to treat blood pressure, serum lipid or glucose metabolism
- No use of dietary supplements or an investigational product within another biomedical within the previous 1-month
- 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
Who cannot join
- High habitual dietary magnesium intake
- 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 or medication known to treat blood pressure, serum lipid or glucose metabolism
- Use of dietary supplements or an investigational product within another biomedical within the previous 1-month
- 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.
About this study
Official title: The Effects of Magnesium on Vascular Stiffness: A Long-term Study in Healthy Overweight and Slightly Obese Men and Women
Observational epidemiologic studies have observed an inverse relationship between daily dietary magnesium intake and blood pressure (BP). Except for BP, 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. To examine the integrated effects of interventions on cardiovascular risk, vascular stiffness may therefore serve as a marker at the later stage of cardiovascular disease development.
Therefore, it is imperative to examine in a 24-week, randomized, double-blind, placebo-controlled, two-way parallel-group human intervention study, the effect of magnesium on vascular stiffness. Focus will be on carotid-femoral pulse wave velocity (PWV), the gold standard for the evaluation of vascular elasticity, to quantify vascular stiffness. Urinary excretion of magnesium will be used to assess dietary magnesium uptake. Furthermore, time courses of an increased magnesium intake on changes in BP, other markers reflecting vascular function, and plasma biomarkers related to low-grade inflammation and vascular activity will be measured to unravel possible cause-effect relationships.
- Conditions
- Metabolic Syndrome, Obesity
- Being tested
- Magnesium Citrate, Placebo
- Keywords
- Metabolic Syndrome, Obesity, Magnesium Supplementation, Vascular Stiffness, Vascular Function
- Medical subject headings
- Metabolic Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium CitrateDietary supplement
One capsule thrice daily that contains magnesium citrate (total daily dose: 350 mg elemental magnesium) at breakfast, lunch and dinner for 24 weeks
PlaceboDietary supplement
One capsule thrice daily that contains placebo at breakfast, lunch and dinner for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Magnesium Citrate | Experimental | Not described Receives: Dietary Supplement: Magnesium Citrate |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular stiffness: effects of magnesium citrate supplementation
Carotid-femoral pulse wave velocity (PWV)
Measured: Baseline (0 weeks) and after medium-term (12 weeks) and long-term (24 weeks) magnesium citrate supplementation
Secondary outcomes (3)
Vascular function markers: effects of magnesium citrate supplementation
Flow-mediated dilation (FMD) of the brachial artery, pulse wave analysis (PWA) (also at 12 weeks), peripheral arterial tonometry (PAT) and retinal microvascular diameters (also at 12 weeks)
Measured: Baseline (0 weeks) and after long-term (24 weeks) magnesium citrate supplementation
Metabolic risk markers related to the metabolic syndrome: effects of magnesium citrate supplementation
Biomarkers for low-grade inflammation and endothelial activation
Measured: Baseline (0 weeks) and after medium-term (12 weeks) and long-term (24 weeks) magnesium citrate supplementation
Blood pressure: effects of magnesium citrate supplementation
Office (also at 12 weeks) and 24-hour ambulatory blood pressure
Measured: Baseline (0 weeks) and after long-term (24 weeks) magnesium citrate supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Top Institute Food and Nutrition
- Responsible party
- Sponsor
- Investigators
- Ronald P Mensink, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235805
- Sponsor's protocol ID
- MEC 14-3-021
- Status last verified
- Sep 2015
- First submitted
- 8 Sep 2014
- Last updated
- 15 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Schutten JC, Joris PJ, Minovic I, Post A, van Beek AP, de Borst MH, Mensink RP, Bakker SJL. Long-term magnesium supplementation improves glucocorticoid metabolism: A post-hoc analysis of an intervention trial. Clin Endocrinol (Oxf). 2021 Feb;94(2):150-157. doi: 10.1111/cen.14350. Epub 2020 Oct 26.
PubMed 33030273Joris PJ, Plat J, Bakker SJ, Mensink RP. Long-term magnesium supplementation improves arterial stiffness in overweight and obese adults: results of a randomized, double-blind, placebo-controlled intervention trial. Am J Clin Nutr. 2016 May;103(5):1260-6. doi: 10.3945/ajcn.116.131466. Epub 2016 Apr 6.
PubMed 27053384
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Magnesium on Vascular Stiffness: A Long-term Study in Healthy Overweight and Slightly Obese Men and Women
- ClinicalTrials.gov ID
- NCT02235805
- Acronym / sponsor ID
- MEC 14-3-021
- Conditions
- Metabolic Syndrome, Obesity
- Keywords
- Metabolic Syndrome, Obesity, Magnesium Supplementation, Vascular Stiffness, Vascular Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Top Institute Food and Nutrition
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 10 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational epidemiologic studies have observed an inverse relationship between daily dietary magnesium intake and blood pressure (BP). Except for BP, 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. To examine the integrated effects of interventions on cardiovascular risk, vascular stiffness may therefore serve as a marker at the later stage of cardiovascular disease development.
Therefore, it is imperative to examine in a 24-week, randomized, double-blind, placebo-controlled, two-way parallel-group human intervention study, the effect of magnesium on vascular stiffness. Focus will be on carotid-femoral pulse wave velocity (PWV), the gold standard for the evaluation of vascular elasticity, to quantify vascular stiffness. Urinary excretion of magnesium will be used to assess dietary magnesium uptake. Furthermore, time courses of an increased magnesium intake on changes in BP, other markers reflecting vascular function, and plasma biomarkers related to low-grade inflammation and vascular activity will be measured to unravel possible cause-effect relationships.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium Citrate | Experimental | Dietary Supplement: Magnesium Citrate |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (16 listed)
- High habitual dietary magnesium intake
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium CitrateOne capsule thrice daily that contains magnesium citrate (total daily dose: 350 mg elemental magnesium) at breakfast, lunch and dinner for 24 weeks | Dietary supplement | Magnesium Citrate |
| PlaceboOne capsule thrice daily that contains placebo at breakfast, lunch and dinner for 24 weeks | Dietary supplement | Placebo |
Primary outcome
Vascular stiffness: effects of magnesium citrate supplementation
Time frame: Baseline (0 weeks) and after medium-term (12 weeks) and long-term (24 weeks) magnesium citrate supplementation
Carotid-femoral pulse wave velocity (PWV)
3 secondary outcomes
Vascular function markers: effects of magnesium citrate supplementation
Time frame: Baseline (0 weeks) and after long-term (24 weeks) magnesium citrate supplementation
Metabolic risk markers related to the metabolic syndrome: effects of magnesium citrate supplementation
Time frame: Baseline (0 weeks) and after medium-term (12 weeks) and long-term (24 weeks) magnesium citrate supplementation
Blood pressure: effects of magnesium citrate supplementation
Time frame: Baseline (0 weeks) and after long-term (24 weeks) magnesium citrate supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2015.
- Derived from this study: PubMed 33030273Schutten JC, Joris PJ, Minovic I, Post A, van Beek AP, de Borst MH, Mensink RP, Bakker SJL. Long-term magnesium supplementation improves glucocorticoid metabolism: A post-hoc analysis of an intervention trial. Clin Endocrinol (Oxf). 2021 Feb;94(2):150-157. doi: 10.1111/cen.14350. Epub 2020 Oct 26.
- Derived from this study: PubMed 27053384Joris PJ, Plat J, Bakker SJ, Mensink RP. Long-term magnesium supplementation improves arterial stiffness in overweight and obese adults: results of a randomized, double-blind, placebo-controlled intervention trial. Am J Clin Nutr. 2016 May;103(5):1260-6. doi: 10.3945/ajcn.116.131466. Epub 2016 Apr 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald P Mensink, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium Citrate in people with Metabolic Syndrome and Obesity, run by Maastricht University Medical Center 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 18 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: finished, as of the sponsor's last update on 15 Sep 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular stiffness: effects of magnesium citrate supplementation (time frame: Baseline (0 weeks) and after medium-term (12 weeks) and long-term (24 weeks) magnesium citrate supplementation). 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 NCT02235805, 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 Sep 2015.