Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
We analysed whether magnesium supplementation affected insulin sensitivity and Blood Pressure (BP) in apparently healthy Korean subjects as well as in individuals with diabetes and hypertension.
Ethics approval
Ethics approval received from the Food Institutional Review Board of Pusan National University Hospital on the 3rd January 2006 (ref: 2006-01).
Study design
Randomised double-blinded controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Overweight, obesity
Intervention
12.3 mmol (300 mg) of elemental magnesium per day in the form of magnesium oxide or placebo. The total duration of treatment and the total duration of follow up are both 12 weeks (i.e., no follow-up).
Intervention type
Supplement
Phase
Not Specified
Drug names
Magnesium supplementation
Primary outcome measures
1. The HOMeostasis model Assessment of Insulin Resistance (HOMA-IR)
2. Quantitative Insulin Sensitivity Check Index (QUICKI)
3. Systolic BP
4. Diastolic BP
Primary outcomes measured at baseline and 12 weeks (at the end of this study).
Secondary outcome measures
1. Lipids
2. Serum trace minerals (magnesium, calcium, and phosphorus)
Secondary outcomes measured at baseline and 12 weeks (at the end of this study).
Overall trial start date
04/01/2006
Overall trial end date
08/01/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 30 - 60 years
2. Body mass index greater than or equal to 23 kg/m^2
3. Have not taken any supplements or medications, including anti-diabetic drugs, anti-hypertensive drugs, steroids, or hormonal products, during the previous 4 weeks
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
156
Participant exclusion criteria
1. Pregnant women
2. Those suffering from chronic illnesses, including:
2.1. Chronic liver and renal diseases
2.2. Severe bradycardia
2.3. Myasthenia gravis
2.4. Hypermagnesemia
Recruitment start date
04/01/2006
Recruitment end date
08/01/2006
Locations
Countries of recruitment
Korea, South
Trial participating centre
Family Medicine
Busan
602-739
Korea, South
Sponsor information
Organisation
TEI (Trace Elements Incorporated) Korea (South Korea)
Sponsor details
Cambridge B/D 2F
1461-15
Seocho-dong
Seocho-gu
Seoul
137-070
Korea
South
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
TEI (Trace Elements Incorporated) Korea (South Korea)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary