Considering the background information given in the previous paragraph, the following research question has been formulated:What is the long-term (24 weeks) effect of magnesium citrate (total daily dose: 350 mg elemental magnesium) on vascular…
ID
Source
Brief title
Condition
- Lipid metabolism disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the difference in response on vascular stiffness
measured from carotid-femoral PWV:
Between overweight and slightly obese participants that received magnesium
citrate (total daily dose: 350 mg elemental magnesium) or a placebo for 24
weeks
Secondary outcome
Secondary endpoints are effects and changes over time of an increased magnesium
intake on BP, other markers reflecting vascular function (e.g. pulse wave
analysis (PWA), flow-mediated dilation (FMD), finger peripheral arterial
tonometry (PAT) and microvascular diameters), and plasma biomarkers related to
low-grade inflammation and vascular activity.
Background 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 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. To examine the integrated effects of interventions on cardiovascular
risk, vascular stiffness may therefore serve as a marker at the later stage of
cardiovascular disease development.
Study objective
Considering the background information given in the previous paragraph, the
following research question has been formulated:
What is the long-term (24 weeks) effect of magnesium citrate (total daily dose:
350 mg elemental magnesium) on vascular stiffness measured from carotid-femoral
pulse wave velocity (PWV) in healthy overweight and slightly obese men and
women?
Study design
At baseline, all participants have to attend the research facilities to perform
the measurements. Before the test day, a fasting blood sample will be drawn,
24-hour ambulatory BP measurements will be performed and 24-hour urine will be
collected.
After the first test day (baseline (BL) measurement), the overweight and
slightly obese participants will be randomly assigned to receive magnesium
citrate or a placebo for 24 weeks. During this period, subjects will visit our
research facilities every 4 weeks to receive new supplies. After 12 and 24
weeks (follow-up (FU) measurements), measurements will be repeated.
Intervention
After the first test day, the overweight and slightly obese subjects will be
randomly assigned to receive magnesium citrate or a placebo for 24 weeks.
Subjects assigned to the oral magnesium treatment will be instructed to take
one capsule thrice daily that contains magnesium citrate (total daily dose: 350
mg elemental magnesium) at breakfast, lunch and dinner for 24 weeks. Magnesium
citrate will be administered because of its superior bioavailability over other
formulations.
Subjects assigned to the placebo treatment will undergo the same tests, but
will be instructed to take one capsule thrice daily that contains placebo
(identical in color, shape, taste and smell to the capsules containing
magnesium citrate) for 24 weeks.
Study burden and risks
Before the start of the study, subjects will attend the research facilities for
a screening visit. During this visit, anthropometric measurements (weight,
length, body mass index) will be performed and BP will be determined. Dietary
magnesium intake will be assessed using a questionnaire. In addition, a venous
blood sample will be drawn for analysis of serum total cholesterol and
triacylglycerol concentrations, and plasma glucose concentrations.
Following screening (30 minutes), all participants will visit our research
facilities at the MRUM for 120 minutes (BL measurements). Before the test day,
a fasting blood sample will be drawn (20 minutes), 24-hour ambulatory BP
measurements will be performed and 24-hour urine will be collected. In
addition, subjects will visit our research facilities every 4 weeks to receive
new supplies. After 12 and 24 weeks, measurements will be repeated (FU
measurements). Time investment at 12 and 24 weeks will be 140 minutes. Total
time investment for the overweight and slightly obese subjects will be
approximately 540 minutes (9 hours).
The amount of blood drawn will be 219 mL (9.0 mL during the screening visit,
35.0 mL before each test day and 35.0 mL at each test day) during the whole
study.
No direct health benefit for the participants is expected. Subjects assigned to
receive magnesium citrate will consume safe and commercially available
products. Only diarrhea, and unspecific mild abdominal and bone pain have been
reported after consumption of magnesium supplements. The risks of participation
are addressed.
Universiteitssingel 50
Maastricht 6229 ER
NL
Universiteitssingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL48784.068.14 |