Status:
COMPLETED
Magnesium and Vascular Stiffness
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
Top Institute Food and Nutrition
Conditions:
Metabolic Syndrome
Obesity
Eligibility:
All Genders
45-70 years
Phase:
NA
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 ca...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT02235805
Start Date
September 1 2014
End Date
September 1 2015
Last Update
September 15 2015
Active Locations (1)
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1
Maastricht University Medical Center
Maastricht, Netherlands