Magnesium DeficiencyNCT02674789
Ionized Magnesium in Athletes
A study testing Exercise protocol in people with Magnesium Deficiency, run by Wageningen University.
Trial summary
Ionized magnesium variation is measured during a normal day and again during a day with an exercise protocol of 90 minutes. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Magnesium Deficiency
- What is being tested?
- Exercise protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Mar 2016
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18 - 45 y
- BMI: 18.5 - 25
- Minimal of 5 hours of training per week, for at least 2 years
- Used to bike, at least 5 hours per week in high season
- No Mg and / or Ca supplementation during study
- No blood donation, during or in the 6 weeks preliminary the study
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- Suitable veins
- No chronic medication, with the exception of paracetamol and or birth control
- No antibiotics in the month preliminary the study
- Good health
- Serum Mg > 0.7 mmol/L
- Willing to give blood
- Able to be present and participate at all test days
Who cannot join
- Chronical illness
- Use of medication with the exception of paracetamol and or birth control
- Mg and or Ca supplementation use
- Inadequate Mg intake (according to FFQ)
- Working at Human Nutrition
- Wageningen University Msc thesis or internship at Human Nutrition
- Participating in other scientific research (with the exception of EetMeetWeet)
About this study
Official title: Ionized Magnesium Concentration in Athletes and Exercise Induced Changes in Ionized Magnesium
Ionized magnesium variation is measured during a normal day and again during a day with an exercise protocol of 90 minutes.
Read the detailed description
Magnesium is an essential micronutrient for health and exercise performance. Deficiencies are common, especially in case of insufficient diets. Athletes are a population at risk of magnesium deficiency, as they can have strong nutritional (dis)believes and increased losses through sweat. That is why monitoring magnesium status in athletes is very important. Ionized magnesium is the active form of total magnesium, this value might be even more important than total magnesium. However, whether ionized magnesium is influenced by day variation is not clear yet. In addition: one bout of exercise can change magnesium status and probably ionized magnesium status. For people active in sports it is important to be aware of this variation in magnesium status, to prevent the diagnosis of false inadequate magnesium status. Therefore it is the aim of this proposal to determine whether ionized magnesium varies within one day and whether it changes after an acute bout of exercise.
Objective:
The main objective is to investigate whether ionized magnesium concentration varies during one day, and whether it is changed after one bout of exercise
Study design:
This will be a cross-over design. With screening and preliminary tests before the exercise test day and the non-exercise test day. The order in which exercise day and non-exercise day will be done, will be randomly divided between the participants.
Intervention:
A rest day and an exercise day At exercise day: an exercise test of 90 min at 70% of VO2max. Blood samples are taken at set time points during rest day and exercise day
- Conditions
- Magnesium Deficiency
- Being tested
- Exercise protocol
- Keywords
- Exercise, Athletes, Ionized Magnesium, Variation, Blood
- Medical subject headings
- Magnesium Deficiency, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise protocolBehavioural
70% VO2max bike ergometer test for 90 minutes
| Study group | Role | What they receive |
|---|---|---|
| Exercise day | Experimental | Behavioral intervention: 90min bike ergometer test at 70% of VO2max. Blood samples are collected at set time points (08:30, 11:00, 12:30, 13:30, 15:00, 16:00 and 18:30). Blood samples are analyzed on the pHOx analyzer for their ionized magnesium concentration. And on the Dimension Vista 1500 from Siemens for their total magnesium concentration. Receives: Behavioral: Exercise protocol |
| Non exercise day (Rest day) | No intervention | No exercise protocol. Estimating daily variation of magnesium concentration. Blood samples are collected at set time points (08:30, 11:00, 12:30, 13:30, 15:00, 16:00 and 18:30). Blood samples are analyzed on the pHOx analyzer for their ionized magnesium concentration. And on the Dimension Vista 1500 from Siemens for their total magnesium concentration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood samples analyzed on the pHOx analyzer for their ionized magnesium concentration
blood
Measured: Blood samples are collected at 7 set time points during one day
Secondary outcomes (1)
blood samples are analyzed on the Dimension Vista 1500 of Siemens for their total magnesium concentration
blood plasma
Measured: Blood samples are collected at 7 set time points during one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startDec 2015
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Gelderse Vallei Hospital
- Responsible party
- Sponsor
- Investigators
- Jacqueline Klein Gunnewiek, Phd, Principal investigator, Gelderse Vallei Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02674789
- Sponsor's protocol ID
- NL54333.081.15
- Status last verified
- Feb 2016
- First submitted
- 9 Dec 2015
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Participants receive a letter with their personal information. VO2max, body weight and height, total Magnesium and ionized magnesium will be communicated.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ionized Magnesium Concentration in Athletes and Exercise Induced Changes in Ionized Magnesium
- ClinicalTrials.gov ID
- NCT02674789
- Acronym / sponsor ID
- NL54333.081.15
- Conditions
- Magnesium Deficiency
- Keywords
- Exercise, Athletes, Ionized Magnesium, Variation, Blood
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Gelderse Vallei Hospital
- Study start
- Dec 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 4 Feb 2016 (estimated)
- 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.
Ionized magnesium variation is measured during a normal day and again during a day with an exercise protocol of 90 minutes.
Detailed description
Magnesium is an essential micronutrient for health and exercise performance. Deficiencies are common, especially in case of insufficient diets. Athletes are a population at risk of magnesium deficiency, as they can have strong nutritional (dis)believes and increased losses through sweat. That is why monitoring magnesium status in athletes is very important. Ionized magnesium is the active form of total magnesium, this value might be even more important than total magnesium. However, whether ionized magnesium is influenced by day variation is not clear yet. In addition: one bout of exercise can change magnesium status and probably ionized magnesium status. For people active in sports it is important to be aware of this variation in magnesium status, to prevent the diagnosis of false inadequate magnesium status. Therefore it is the aim of this proposal to determine whether ionized magnesium varies within one day and whether it changes after an acute bout of exercise.
Objective:
The main objective is to investigate whether ionized magnesium concentration varies during one day, and whether it is changed after one bout of exercise
Study design:
This will be a cross-over design. With screening and preliminary tests before the exercise test day and the non-exercise test day. The order in which exercise day and non-exercise day will be done, will be randomly divided between the participants.
Intervention:
A rest day and an exercise day At exercise day: an exercise test of 90 min at 70% of VO2max. Blood samples are taken at set time points during rest day and exercise day
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise day | Experimental | Behavioral: Exercise protocolBehavioral intervention: 90min bike ergometer test at 70% of VO2max. Blood samples are collected at set time points (08:30, 11:00, 12:30, 13:30, 15:00, 16:00 and 18:30). Blood samples are analyzed on the pHOx analyzer for their ionized magnesium concentration. And on the Dimension Vista 1500 from Siemens for their total magnesium concentration. |
| Non exercise day (Rest day) | No intervention | –No exercise protocol. Estimating daily variation of magnesium concentration. Blood samples are collected at set time points (08:30, 11:00, 12:30, 13:30, 15:00, 16:00 and 18:30). Blood samples are analyzed on the pHOx analyzer for their ionized magnesium concentration. And on the Dimension Vista 1500 from Siemens for their total magnesium concentration. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Age: 18 - 45 y
- BMI: 18.5 - 25
- Minimal of 5 hours of training per week, for at least 2 years
- Used to bike, at least 5 hours per week in high season
- No Mg and / or Ca supplementation during study
Key exclusion criteria (7 listed)
- Chronical illness
- Use of medication with the exception of paracetamol and or birth control
- Mg and or Ca supplementation use
- Inadequate Mg intake (according to FFQ)
- Working at Human Nutrition
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 |
|---|---|---|
| Exercise protocol70% VO2max bike ergometer test for 90 minutes | Behavioural | Exercise day |
Primary outcome
Blood samples analyzed on the pHOx analyzer for their ionized magnesium concentration
Time frame: Blood samples are collected at 7 set time points during one day
blood
1 secondary outcome
blood samples are analyzed on the Dimension Vista 1500 of Siemens for their total magnesium concentration
Time frame: Blood samples are collected at 7 set time points during one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
- Individual participant dataSharing planned: Yes. Participants receive a letter with their personal information. VO2max, body weight and height, total Magnesium and ionized magnesium will be communicated.
Related trials for Magnesium Deficiency
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Magnesium in Gastrointestinal Disease
Colitis Ulcerosa, Colitis Ulcerative
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.
Jacqueline Klein Gunnewiek, Phd principal investigator
Gelderse Vallei Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Exercise protocol in people with Magnesium Deficiency, run by Wageningen University.
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 13 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Blood samples analyzed on the pHOx analyzer for their ionized magnesium concentration (time frame: Blood samples are collected at 7 set time points during one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2016; AzTrials last refreshed its copy on 27 Oct 2026.