NCT02151227

Brief Summary

Magnesium is an essential mineral found in many foods; rich sources include whole grains, green leafy vegetables, coffee, and legumes. Magnesium is a critical cofactor in \>300 enzymatic reactions, including those related to energy metabolism. Reduced magnesium intake and serum concentrations have been detected, both cross-sectionally and prospectively,in type 2 diabetes and insulin resistance, hypertension, dyslipidemia, and cardiovascular diseases. Different studies have reported inadequate magnesium intake and low serum magnesium concentrations may correlated also with metabolic syndrome, defined as a cluster of metabolic disorders including obesity, hypertension, dyslipidemia and impaired glucose tolerance or diabetes mellitus. Previous studies on this subject, however, reported contradicting results. Some investigations reported inadequate magnesium intake and low serum magnesium concentrations while others did not. To our knowledge, the epidemiological evidence on the relation between dietary magnesium intake and risk of metabolic syndrome has not yet been summarized.Therefore, the investigators will perform a systematic review and dose-response meta-analysis to assess the association between dietary and circulating magnesium level and risk of metabolic syndrome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 30, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 30, 2014

Status Verified

December 1, 2014

Enrollment Period

3 months

First QC Date

May 28, 2014

Last Update Submit

December 25, 2014

Conditions

Keywords

Meta-AnalysisMetabolic SyndromeMagnesiumDose Response EffectSystematic Review

Outcome Measures

Primary Outcomes (1)

  • Metabolic syndrome risk ratios (Odds ratio, Relative risk, Hazard ratio)

    Baseline

Secondary Outcomes (1)

  • Serum magnesium concentration (mg/dL, mmol/L)

    Baseline

Study Arms (1)

magnesium intake categories

comparators: categories of magnesium intake except lowest category of magnesium intake , controls: lowest category of magnesium intake

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult population: 18 years old and older

You may qualify if:

  • Dietary studies in humans 18 years old and older
  • Randomized controlled study, Cohort study, Nested case-control study, Case-control study, Cross-sectional study
  • The exposure of interest is magnesium intake (mg/day) or serum magnesium concentration(mmol/L, mg/dL)

You may not qualify if:

  • Non-human studies
  • Authors did not make serum magnesium concentration measurement;
  • The outcome values can not be used for meta-analysis
  • Duplicated articles.
  • Studies are not published as full reports, such as conference abstracts and letters to editors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sang-Yhun Ju

Seoul, 150-713, South Korea

Location

Related Publications (2)

  • Ju SY, Choi WS, Ock SM, Kim CM, Kim DH. Dietary magnesium intake and metabolic syndrome in the adult population: dose-response meta-analysis and meta-regression. Nutrients. 2014 Dec 22;6(12):6005-19. doi: 10.3390/nu6126005.

  • La SA, Lee JY, Kim DH, Song EL, Park JH, Ju SY. Low Magnesium Levels in Adults with Metabolic Syndrome: a Meta-Analysis. Biol Trace Elem Res. 2016 Mar;170(1):33-42. doi: 10.1007/s12011-015-0446-9. Epub 2015 Jul 26.

Related Links

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Sang-yhun Ju, Ph.D.

    Department of Family Medicine, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D., Clinical Associate Professor

Study Record Dates

First Submitted

May 28, 2014

First Posted

May 30, 2014

Study Start

June 1, 2014

Primary Completion

September 1, 2014

Study Completion

December 1, 2014

Last Updated

December 30, 2014

Record last verified: 2014-12

Locations