Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/11/2007
Date assigned
18/12/2007
Last edited
18/12/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Sang Yeoup Lee

ORCID ID

Contact details

Family Medicine
Pusan National University Hospital
1-10 Ami-dong
Seo-gu
Busan
602-739
Korea
South

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

http://www.teikorea.com

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

Publication citations

Additional files

Editorial Notes