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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03632590
Other study ID # METc2017/220
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 27, 2018
Est. completion date January 2020

Study information

Verified date August 2018
Source University Medical Center Groningen
Contact Joëlle C Schutten, MSc
Phone +31 50 3612679
Email j.c.schutten@umcg.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Observational epidemiologic studies have observed an inverse relationship between daily dietary magnesium intake and blood pressure. Except for blood pressure, 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. A recently published intervention study showed that oral magnesium citrate supplementation of 350 mg per day for 24 weeks was well-tolerated and improved vascular stiffness by 1.0 m/s. Importantly, it was not established whether the beneficial effect on vascular stiffness was due to the supplementation of magnesium or due to citrate. This may involve effects on gut microbiota and systemic metabolic effects. The current study was designed to (1) reproduce the result of the earlier study and to (2) investigate whether there is a difference between different commonly used magnesium salts (magnesium citrate, magnesium sulphate and magnesium oxide) in terms of effects on vascular stiffness, blood pressure and gut microbiota.


Recruitment information / eligibility

Status Recruiting
Enrollment 162
Est. completion date January 2020
Est. primary completion date January 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Years to 75 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 (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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Magnesium Citrate
450 mg of Magnesium Citrate per day (6 capsules per day) for 24 weeks
Magnesium Sulfate
450 mg of Magnesium Sulfate per day (6 capsules per day) for 24 weeks
Magnesium Oxide
450 mg of Magnesium Oxide per day (6 capsules per day) for 24 weeks
Drug:
Placebo
The placebo capsules will contain starch (Amylum solani) for 24 weeks

Locations

Country Name City State
Netherlands University Medical Center Groningen Groningen

Sponsors (2)

Lead Sponsor Collaborator
University Medical Center Groningen Nedmag Industries Mining and Manufacturing B.V.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in vascular stiffness Measured from carotid-femoral pulse wave velocity (PWV). For this assessment, a SphygmoCor will be used (SphygmoCor v9, AtCor Medical). Baseline, FU-1 (2 weeks), FU-2 (12 weeks), and FU-3 (24 weeks)
Secondary Change in blood pressure Measured from a semi continuous blood pressure monitoring device Baseline, FU-1 (2 weeks), FU-2 (12 weeks), and FU-3 (24 weeks)
Secondary Change in gut microbiota Measured from fecal samples Baseline, FU-1 (2 weeks), FU-2 (12 weeks), and FU-3 (24 weeks)
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