NCT04216836

Brief Summary

This study investigated the effect of magnesium supplementation on exercise performance and functional recovery in recreational endurance athletes in conjunction with measures of blood glucose, lactate, IL-6 and sIL-6R.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

June 28, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 3, 2020

Completed
Last Updated

January 3, 2020

Status Verified

January 1, 2020

Enrollment Period

8 months

First QC Date

September 17, 2019

Last Update Submit

January 1, 2020

Conditions

Magnesium Deficiency

Keywords

MagnesiumSupplementationInterleukin-6Soluble interleukin-6 receptorGlucosePainExercise performanceExercise recoveryDownhill running

Outcome Measures

Primary Outcomes (2)

  • Downhill 10 km treadmill time trial performance

    Maximal 10 km time trial performance on a treadmill

    1 day

  • 24 hr post exercise maximal force testing of the dominant leg on the isokinetic dynamometer

    Maximal force produced from the dominant leg (eccentric and concentric) on an isokinetic dynamometer.

    1 day

Secondary Outcomes (6)

  • Glucose

    up to 2 days

  • Interleukin-6

    up to 2 days

  • Soluble interleukin-6 receptor

    up to 2 days

  • Perceived muscle soreness

    up to 4 days

  • Lactate

    up to 2 days

  • +1 more secondary outcomes

Study Arms (2)

High magnesium diet (SUP condition)

EXPERIMENTAL

Participants followed a low magnesium diet \<260mg/day and consumed 500 mg/day of magnesium oxide. This was separated into 3 capsules, which were consumed at 6 hr intervals each day (8am, 2pm and 8pm). The supplementation period was 1 week.

Dietary Supplement: Magnesium oxide

Low magnesium diet (CON condition)

EXPERIMENTAL

Participants followed a low magnesium diet \<260mg/day and consumed 500 mg/day of placebo (cornflour). This was separated into 3 capsules, which were consumed at 6 hr intervals each day (8am, 2pm and 8pm). The supplementation period was 1 week.

Dietary Supplement: Placebo

Interventions

Magnesium oxideDIETARY_SUPPLEMENT

Magnesium capsule

High magnesium diet (SUP condition)
PlaceboDIETARY_SUPPLEMENT

Cornflour capsule manufactured to mimic the 166.6 mg magnesium capsule.

Low magnesium diet (CON condition)

Eligibility Criteria

Age20 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Regular recreational runner, running around 3 times per week
  • Capable of running 10 km in \~ 40 minutes.

You may not qualify if:

  • Any signs or symptoms of cardiovascular issues.
  • Any recent form of injury or illness.
  • Currently, or in the last 3 months, have consumed multivitamin supplements
  • Currently, or in the last 3 months, have consumed anti-inflammatory medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Worcester

Worcester, Worcestershire, WR1 3AS, United Kingdom

Location

Related Publications (9)

  • Chen HY, Cheng FC, Pan HC, Hsu JC, Wang MF. Magnesium enhances exercise performance via increasing glucose availability in the blood, muscle, and brain during exercise. PLoS One. 2014 Jan 20;9(1):e85486. doi: 10.1371/journal.pone.0085486. eCollection 2014.

    PMID: 24465574BACKGROUND

  • Chen YJ, Chen HY, Wang MF, Hsu MH, Liang WM, Cheng FC. Effects of magnesium on exercise performance and plasma glucose and lactate concentrations in rats using a novel blood-sampling technique. Appl Physiol Nutr Metab. 2009 Dec;34(6):1040-7. doi: 10.1139/H09-105.

    PMID: 20029512BACKGROUND

  • Cheng SM, Yang LL, Chen SH, Hsu MH, Chen IJ, Cheng FC. Magnesium sulfate enhances exercise performance and manipulates dynamic changes in peripheral glucose utilization. Eur J Appl Physiol. 2010 Jan;108(2):363-9. doi: 10.1007/s00421-009-1235-y. Epub 2009 Oct 9.

    PMID: 19816708BACKGROUND

  • Dmitrasinovic G, Pesic V, Stanic D, Plecas-Solarovic B, Dajak M, Ignjatovic S. ACTH, Cortisol and IL-6 Levels in Athletes following Magnesium Supplementation. J Med Biochem. 2016 Nov 2;35(4):375-384. doi: 10.1515/jomb-2016-0021. eCollection 2016 Oct.

    PMID: 28670189BACKGROUND

  • Febbraio MA, Steensberg A, Keller C, Starkie RL, Nielsen HB, Krustrup P, Ott P, Secher NH, Pedersen BK. Glucose ingestion attenuates interleukin-6 release from contracting skeletal muscle in humans. J Physiol. 2003 Jun 1;549(Pt 2):607-12. doi: 10.1113/jphysiol.2003.042374. Epub 2003 Apr 17.

    PMID: 12702735BACKGROUND

  • Glund S, Deshmukh A, Long YC, Moller T, Koistinen HA, Caidahl K, Zierath JR, Krook A. Interleukin-6 directly increases glucose metabolism in resting human skeletal muscle. Diabetes. 2007 Jun;56(6):1630-7. doi: 10.2337/db06-1733. Epub 2007 Mar 15.

    PMID: 17363741BACKGROUND

  • Gray SR, Ratkevicius A, Wackerhage H, Coats P, Nimmo MA. The effect of interleukin-6 and the interleukin-6 receptor on glucose transport in mouse skeletal muscle. Exp Physiol. 2009 Aug;94(8):899-905. doi: 10.1113/expphysiol.2009.048173. Epub 2009 May 29.

    PMID: 19482899BACKGROUND

  • Robson-Ansley P, Cockburn E, Walshe I, Stevenson E, Nimmo M. The effect of exercise on plasma soluble IL-6 receptor concentration: a dichotomous response. Exerc Immunol Rev. 2010;16:56-76.

    PMID: 20839491BACKGROUND

  • Heffernan SM, Horner K, De Vito G, Conway GE. The Role of Mineral and Trace Element Supplementation in Exercise and Athletic Performance: A Systematic Review. Nutrients. 2019 Mar 24;11(3):696. doi: 10.3390/nu11030696.

    PMID: 30909645BACKGROUND

MeSH Terms

Conditions

Magnesium DeficiencyPain

Interventions

Magnesium Oxide

Condition Hierarchy (Ancestors)

Deficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsOxidesOxygen Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 17, 2019

First Posted

January 3, 2020

Study Start

June 28, 2018

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

January 3, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)