- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04216836
One Week of Magnesium Supplementation Lowers IL-6, Perceived Pain and Increases Post Exercise Blood Glucose in Response to Downhill Running
January 1, 2020 updated by: Charles Steward, University of Worcester
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Magnesium status can directly affect circulating glucose concentrations both during and post exercise.
In addition, magnesium supplementation has been shown to reduce circulating IL-6 concentrations post exercise in humans.
It is conceivable that such observations are linked through the role of IL-6 in glucose regulation, possibly in combination with sIL-6R.
Together, magnesium intake may have the potential to effect exercise performance and recovery through glucose availability.
This in turn may be connected to the production of IL-6 and sIL-6R which have been established to influence exercise fatigue and perception of pain (muscle soreness).
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Worcestershire
-
Worcester, Worcestershire, United Kingdom, WR1 3AS
- University of Worcester
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 35 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Regular recreational runner, running around 3 times per week
- Capable of running 10 km in ~ 40 minutes.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: High magnesium diet (SUP condition)
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.
|
Magnesium capsule
|
EXPERIMENTAL: Low magnesium diet (CON condition)
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.
|
Cornflour capsule manufactured to mimic the 166.6 mg magnesium capsule.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Downhill 10 km treadmill time trial performance
Time Frame: 1 day
|
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
Time Frame: 1 day
|
Maximal force produced from the dominant leg (eccentric and concentric) on an isokinetic dynamometer.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose
Time Frame: up to 2 days
|
Capillary blood samples at rest, during, immediately post, 1 hr post and 24 hrs post 10 km downhill time-trial.
A Biosen analyser was used to analyse glucose concentrations.
|
up to 2 days
|
Interleukin-6
Time Frame: up to 2 days
|
Venous blood samples at rest, immediately post, 1hr post and 24 hrs 10 km downhill time trial.
Enzyme-linked immunosorbent assays were used to analyse interleukin-6.
|
up to 2 days
|
Soluble interleukin-6 receptor
Time Frame: up to 2 days
|
Venous blood samples at rest, immediately post, 1hr post and 24 hrs 10 km downhill time trial.
Enzyme-linked immunosorbent assays were used to analyse soluble interleukin-6.
|
up to 2 days
|
Perceived muscle soreness
Time Frame: up to 4 days
|
A 10cm visual analogue scale was used to assess perceived muscle soreness, the scale started at 0 (no pain) and finished at 10 (unbearable pain)
|
up to 4 days
|
Lactate
Time Frame: up to 2 days
|
Capillary blood samples at rest, during, immediately post, 1 hr post and 24 hrs post 10 km downhill time-trial.
A Biosen analyser was used to analyse lactate concentrations.
|
up to 2 days
|
Creatine kinase
Time Frame: up to 2 days
|
Venous blood samples at rest, immediately post, 1hr post and 24 hrs 10 km downhill time trial.
A Reflotron analyser was used to analyse creatine kinase concentrations.
|
up to 2 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 28, 2018
Primary Completion (ACTUAL)
March 1, 2019
Study Completion (ACTUAL)
March 1, 2019
Study Registration Dates
First Submitted
September 17, 2019
First Submitted That Met QC Criteria
January 1, 2020
First Posted (ACTUAL)
January 3, 2020
Study Record Updates
Last Update Posted (ACTUAL)
January 3, 2020
Last Update Submitted That Met QC Criteria
January 1, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SH17180029-R
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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