Magnesium and Vascular Stiffness

Obesity Clinical Trial

Official title:

The Effects of Magnesium on Vascular Stiffness: A Long-term Study in Healthy Overweight and Slightly Obese Men and Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02235805
• Other study ID #: MEC 14-3-021
• Status: Completed
• Phase: N/A
• First received: September 8, 2014
• Last updated: September 14, 2015
• Start date: September 2014
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity

Intervention

Dietary Supplement:
• Magnesium Citrate
One capsule thrice daily that contains magnesium citrate (total daily dose: 350 mg elemental magnesium) at breakfast, lunch and dinner for 24 weeks
• Placebo
One capsule thrice daily that contains placebo at breakfast, lunch and dinner for 24 weeks

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Top Institute Food and Nutrition

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dietary magnesium uptake	24-hour urine samples	Baseline (0 weeks) and after long-term (24 weeks) magnesium citrate supplementation	No
Primary	Vascular stiffness: effects of magnesium citrate supplementation	Carotid-femoral pulse wave velocity (PWV)	Baseline (0 weeks) and after medium-term (12 weeks) and long-term (24 weeks) magnesium citrate supplementation	No
Secondary	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)	Baseline (0 weeks) and after long-term (24 weeks) magnesium citrate supplementation	No
Secondary	Metabolic risk markers related to the metabolic syndrome: effects of magnesium citrate supplementation	Biomarkers for low-grade inflammation and endothelial activation	Baseline (0 weeks) and after medium-term (12 weeks) and long-term (24 weeks) magnesium citrate supplementation	No
Secondary	Blood pressure: effects of magnesium citrate supplementation	Office (also at 12 weeks) and 24-hour ambulatory blood pressure	Baseline (0 weeks) and after long-term (24 weeks) magnesium citrate supplementation	No