Magnesium and Vascular Stiffness

• Register: ClinicalTrials.gov
• Last refreshed on: 28 September 2015
• Main ID: NCT02235805
• Date of registration: 08/09/2014
• Prospective Registration: No
• Primary sponsor: Maastricht University Medical Center
• Public title: Magnesium and Vascular Stiffness
• Scientific title: The Effects of Magnesium on Vascular Stiffness: A Long-term Study in Healthy Overweight and Slightly Obese Men and Women
• Date of first enrolment: September 2014
• Target sample size: 52
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02235805
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
• Phase: N/A

Countries of recruitment

Netherlands

Contacts

• Name: Ronald P Mensink, PhD
• Affiliation: Maastricht University Medical Center

Key inclusion & exclusion 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



Age minimum: 45 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Metabolic Syndrome

Obesity

Intervention(s)

Dietary Supplement: Placebo

Dietary Supplement: Magnesium Citrate

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

Vascular function markers: effects of magnesium citrate supplementation [Time Frame: Baseline (0 weeks) and after 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]

Secondary ID(s)

MEC 14-3-021

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Top Institute Food and Nutrition