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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United Kingdom
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Dietary supplement: Magnesium oxide
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.
Dietary supplement: Placebo
Cornflour capsule manufactured to mimic the 166.6 mg magnesium capsule.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Worcester

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Coventry University
Beijing Sport Uninversity

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 28, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 1, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 3, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 3, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 1, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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