Back to resultsMagnesium and Vascular Stiffness
Primary Purpose
Metabolic Syndrome, Obesity
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Magnesium Citrate
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Metabolic Syndrome focused on measuring Metabolic Syndrome, Obesity, Magnesium Supplementation, Vascular Stiffness, Vascular Function
Eligibility Criteria
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
- Serum triacylglycerol < 4.5 mmol/L
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Maastricht University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Magnesium Citrate
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Vascular stiffness: effects of magnesium citrate supplementation
Carotid-femoral pulse wave velocity (PWV)
Secondary Outcome Measures
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)
Metabolic risk markers related to the metabolic syndrome: effects of magnesium citrate supplementation
Biomarkers for low-grade inflammation and endothelial activation
Blood pressure: effects of magnesium citrate supplementation
Office (also at 12 weeks) and 24-hour ambulatory blood pressure
Full Information
NCT ID
NCT02235805
First Posted
September 8, 2014
Last Updated
September 14, 2015
Sponsor
Maastricht University Medical Center
Collaborators
Top Institute Food and Nutrition
1. Study Identification
Unique Protocol Identification Number
NCT02235805
Brief Title
Magnesium and Vascular Stiffness
Official Title
The Effects of Magnesium on Vascular Stiffness: A Long-term Study in Healthy Overweight and Slightly Obese Men and Women
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Top Institute Food and Nutrition
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Obesity
Keywords
Metabolic Syndrome, Obesity, Magnesium Supplementation, Vascular Stiffness, Vascular Function
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Magnesium Citrate
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Magnesium Citrate
Intervention Description
One capsule thrice daily that contains magnesium citrate (total daily dose: 350 mg elemental magnesium) at breakfast, lunch and dinner for 24 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
One capsule thrice daily that contains placebo at breakfast, lunch and dinner for 24 weeks
Primary Outcome Measure Information:
Title
Vascular stiffness: effects of magnesium citrate supplementation
Description
Carotid-femoral pulse wave velocity (PWV)
Time Frame
Baseline (0 weeks) and after medium-term (12 weeks) and long-term (24 weeks) magnesium citrate supplementation
Secondary Outcome Measure Information:
Title
Vascular function markers: effects of magnesium citrate supplementation
Description
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)
Time Frame
Baseline (0 weeks) and after long-term (24 weeks) magnesium citrate supplementation
Title
Metabolic risk markers related to the metabolic syndrome: effects of magnesium citrate supplementation
Description
Biomarkers for low-grade inflammation and endothelial activation
Time Frame
Baseline (0 weeks) and after medium-term (12 weeks) and long-term (24 weeks) magnesium citrate supplementation
Title
Blood pressure: effects of magnesium citrate supplementation
Description
Office (also at 12 weeks) and 24-hour ambulatory blood pressure
Time Frame
Baseline (0 weeks) and after long-term (24 weeks) magnesium citrate supplementation
Other Pre-specified Outcome Measures:
Title
Dietary magnesium uptake
Description
24-hour urine samples
Time Frame
Baseline (0 weeks) and after long-term (24 weeks) magnesium citrate supplementation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Serum triacylglycerol < 4.5 mmol/L
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald P Mensink, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
33030273
Citation
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.
Results Reference
derived
PubMed Identifier
27053384
Citation
Joris 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.
Results Reference
derived
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Magnesium and Vascular Stiffness
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