Magnesium and Vascular Stiffness

• Status: Unknown status
• Trial end date: 2020-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This four-arm randomized controlled trial was designed to study the effects of magnesium supplements (total daily dose: 450 mg elemental magnesium) on vascular stiffness in healthy overweight and slightly obese men and women. In addition, the effects of magnesium supplements on blood pressure and gut microbiota will be evaluated. Three groups will receive magnesium supplements (magnesium oxide, magnesium citrate or magnesium sulphate) and one group will receive a placebo.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Medical Center Groningen
• Collaborator: Nedmag Industries Mining and Manufacturing B.V.
• Treatments: Citric Acid; Magnesium citrate; Magnesium Oxide; Magnesium Sulfate

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 (further testing is recommended for excessive hyperlipidemia (serum total cholesterol ≥ 8.0 mmol/L) according to the Standard for cardiovascular risk management of the Dutch general practitioners community (NHG))

• Serum triacylglycerol < 4.5 mmol/L (Friedewald formula)

• 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

• No use of magnesium supplements

• 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

• Written informed consent

Exclusion Criteria:

• High habitual dietary magnesium intake (defined as urinary magnesium excretion of 7.0 or 5.9 mmol/24-h or more for men and women, respectively)

• 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

• Use of magnesium supplements

• 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