- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02674789
Ionized Magnesium in Athletes
Ionized Magnesium Concentration in Athletes and Exercise Induced Changes in Ionized Magnesium
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise day
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.
|
70% VO2max bike ergometer test for 90 minutes
|
No Intervention: Non exercise day (Rest day)
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Blood samples are collected at 7 set time points during one day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
blood plasma
|
Blood samples are collected at 7 set time points during one day
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jacqueline Klein Gunnewiek, Phd, Gelderse Vallei Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL54333.081.15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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