Magnesium DeficiencyNCT04216836
One Week of Magnesium Supplementation Lowers IL-6, Perceived Pain and Increases Post Exercise Blood Glucose in Response to Downhill Running
A study testing Magnesium oxide in people with Magnesium Deficiency, run by University of Worcester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Magnesium Deficiency
- What is being tested?
- Magnesium oxide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Jun 2018to 1 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Regular recreational runner, running around 3 times per week
- Capable of running 10 km in ~ 40 minutes.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Worcester
Worcester, Worcestershire, WR1 3AS
About this study
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.
Read the 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).
- Conditions
- Magnesium Deficiency
- Being tested
- Magnesium oxide, Placebo
- Keywords
- Magnesium, Supplementation, Interleukin-6, Soluble interleukin-6 receptor, Glucose, Pain, Exercise performance, Exercise recovery, Downhill running
- Medical subject headings
- Magnesium Deficiency, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium oxideDietary supplement
Magnesium capsule
PlaceboDietary supplement
Cornflour capsule manufactured to mimic the 166.6 mg magnesium capsule.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Downhill 10 km treadmill time trial performance
Maximal 10 km time trial performance on a treadmill
Measured: 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.
Measured: 1 day
Secondary outcomes (6)
Glucose
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.
Measured: up to 2 days
Interleukin-6
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.
Measured: up to 2 days
Soluble interleukin-6 receptor
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.
Measured: up to 2 days
Perceived muscle soreness
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)
Measured: up to 4 days
Lactate
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.
Measured: up to 2 days
Creatine kinase
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.
Measured: up to 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start28 Jun 2018
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Magnesium DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Sport University, Coventry University
- Responsible party
- Principal investigator, Charles Steward, University of Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216836
- Sponsor's protocol ID
- SH17180029-R
- Status last verified
- Jan 2020
- First submitted
- 17 Sep 2019
- Last updated
- 3 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 24465574Chen 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.
PubMed 20029512Cheng 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.
PubMed 19816708Dmitrasinovic 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.
PubMed 28670189Febbraio 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.
PubMed 12702735Glund 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.
PubMed 17363741Gray 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.
PubMed 19482899Robson-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.
PubMed 20839491Heffernan 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.
PubMed 30909645
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Week of Magnesium Supplementation Lowers IL-6, Perceived Pain and Increases Post Exercise Blood Glucose in Response to Downhill Running
- ClinicalTrials.gov ID
- NCT04216836
- Acronym / sponsor ID
- SH17180029-R
- Conditions
- Magnesium Deficiency
- Keywords
- Magnesium, Supplementation, Interleukin-6, Soluble interleukin-6 receptor, Glucose, Pain, Exercise performance, Exercise recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of WorcesterUniversity, hospital or other
- Collaborators
- Beijing Sport University, Coventry University
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 3 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High magnesium diet (SUP condition) | Experimental | Dietary Supplement: Magnesium oxideParticipants 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. |
| Low magnesium diet (CON condition) | Experimental | Dietary Supplement: PlaceboParticipants 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. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Regular recreational runner, running around 3 times per week
- Capable of running 10 km in ~ 40 minutes.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium oxideMagnesium capsule | Dietary supplement | High magnesium diet (SUP condition) |
| PlaceboCornflour capsule manufactured to mimic the 166.6 mg magnesium capsule. | Dietary supplement | Low magnesium diet (CON condition) |
Primary outcome
Downhill 10 km treadmill time trial performance
Time frame: 1 day
Maximal 10 km time trial performance on a treadmill
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.
6 secondary outcomes
Glucose
Time frame: up to 2 days
Interleukin-6
Time frame: up to 2 days
Soluble interleukin-6 receptor
Time frame: up to 2 days
Perceived muscle soreness
Time frame: up to 4 days
Lactate
Time frame: up to 2 days
Creatine kinase
Time frame: up to 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
- Background: PubMed 24465574Chen 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.
- Background: PubMed 20029512Chen 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.
- Background: PubMed 19816708Cheng 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.
- Background: PubMed 28670189Dmitrasinovic 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.
- Background: PubMed 12702735Febbraio 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.
- Background: PubMed 17363741Glund 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.
- Background: PubMed 19482899Gray 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.
- Background: PubMed 20839491Robson-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.
- Background: PubMed 30909645Heffernan 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.
- Individual participant dataSharing planned: No
Related trials for Magnesium Deficiency
Active, not recruiting
Efficacy of MAGNESIO TOTAL on Sleep Quality and Quality of Life in Adults
Sleep Quality, Magnesium Deficiency
RecruitingObservational study
Magnesium in Gastrointestinal Disease
Colitis Ulcerosa, Colitis Ulcerative
RecruitingPhase 4
Magnesium Deficiency In Patients Hospitalized in Internal Medicine Wards
Hypomagnesemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium oxide in people with Magnesium Deficiency, run by University of Worcester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Downhill 10 km treadmill time trial performance (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04216836, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2020.