The effects of magnesium on vascular stiffness: a long-term study in healthy overweight and slightly obese men and women.

Completed

• Conditions: Insulin Resistance Syndrome; Metabolic Syndrome; Syndrome X; 10013317

• Registration Number: NL-OMON42248
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2015-09-11
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 58

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 14 (women) or 21 (men) 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 14 (women) or 21 (men) 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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the difference in response on vascular stiffness<br /><br>measured from carotid-femoral PWV:<br /><br><br /><br>Between overweight and slightly obese participants that received magnesium<br /><br>citrate (total daily dose: 350 mg elemental magnesium) or a placebo for 24<br /><br>weeks</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are effects and changes over time of an increased magnesium<br /><br>intake on BP, other markers reflecting vascular function (e.g. pulse wave<br /><br>analysis (PWA), flow-mediated dilation (FMD), finger peripheral arterial<br /><br>tonometry (PAT) and microvascular diameters), and plasma biomarkers related to<br /><br>low-grade inflammation and vascular activity.</p><br>