Effect of oral magnesium supplementation on insulin sensitivity and blood pressure in apparently healthy overweight adults: a randomised double-blinded controlled trial

ISRCTN	ISRCTN92199360
DOI	https://doi.org/10.1186/ISRCTN92199360
Secondary identifying numbers	N/A

Submission date: 27/11/2007
Registration date: 18/12/2007
Last edited: 08/04/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Sang Yeoup Lee
Scientific

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

Study information

Study design	Randomised double-blinded controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Effect of oral magnesium supplementation on insulin sensitivity and blood pressure in apparently healthy overweight adults: a randomised double-blinded controlled trial
Study objectives	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(s)	Ethics approval received from the Food Institutional Review Board of Pusan National University Hospital on the 3rd January 2006 (ref: 2006-01).
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	04/01/2006
Completion date	08/01/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	156
Total final enrolment	155
Key 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
Key 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
Date of first enrolment	04/01/2006
Date of final enrolment	08/01/2006

Locations

Countries of recruitment

Korea, South

Study participating centre

Family Medicine

Busan
602-739
Korea, South

Sponsor information

TEI (Trace Elements Incorporated) Korea (South Korea)
Industry

Cambridge B/D 2F
1461-15
Seocho-dong
Seocho-gu
Seoul
137-070
Korea, South

Website	http://www.teikorea.com
"ROR"	https://ror.org/00zhe2a05

Funders

Funder type

Industry

TEI (Trace Elements Incorporated) Korea (South Korea)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/12/2009	08/04/2021	Yes	No

Editorial Notes

08/04/2021: Publication reference and total final enrolment added.