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Ionized Magnesium in Athletes

Primary Purpose

Magnesium Deficiency

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise protocol
Sponsored by
Wageningen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Magnesium Deficiency focused on measuring Exercise, Athletes, Ionized Magnesium, Variation, Blood

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Exercise day

    Non exercise day (Rest day)

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Blood samples analyzed on the pHOx analyzer for their ionized magnesium concentration
    blood

    Secondary Outcome Measures

    blood samples are analyzed on the Dimension Vista 1500 of Siemens for their total magnesium concentration
    blood plasma

    Full Information

    First Posted
    December 9, 2015
    Last Updated
    February 1, 2016
    Sponsor
    Wageningen University
    Collaborators
    Gelderse Vallei Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02674789
    Brief Title
    Ionized Magnesium in Athletes
    Official Title
    Ionized Magnesium Concentration in Athletes and Exercise Induced Changes in Ionized Magnesium
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2015 (undefined)
    Primary Completion Date
    March 2016 (Anticipated)
    Study Completion Date
    March 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Wageningen University
    Collaborators
    Gelderse Vallei Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Magnesium Deficiency
    Keywords
    Exercise, Athletes, Ionized Magnesium, Variation, Blood

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    18 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Exercise day
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Non exercise day (Rest day)
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Exercise protocol
    Intervention Description
    70% VO2max bike ergometer test for 90 minutes
    Primary Outcome Measure Information:
    Title
    Blood samples analyzed on the pHOx analyzer for their ionized magnesium concentration
    Description
    blood
    Time Frame
    Blood samples are collected at 7 set time points during one day
    Secondary Outcome Measure Information:
    Title
    blood samples are analyzed on the Dimension Vista 1500 of Siemens for their total magnesium concentration
    Description
    blood plasma
    Time Frame
    Blood samples are collected at 7 set time points during one day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jacqueline Klein Gunnewiek, Phd
    Organizational Affiliation
    Gelderse Vallei Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Participants receive a letter with their personal information. VO2max, body weight and height, total Magnesium and ionized magnesium will be communicated.

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    Ionized Magnesium in Athletes

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