NCT02674789

Brief Summary

Ionized magnesium variation is measured during a normal day and again during a day with an exercise protocol of 90 minutes.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 4, 2016

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

February 4, 2016

Status Verified

February 1, 2016

Enrollment Period

3 months

First QC Date

December 9, 2015

Last Update Submit

February 1, 2016

Conditions

Keywords

ExerciseAthletesIonized MagnesiumVariationBlood

Outcome Measures

Primary Outcomes (1)

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

    blood

    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 samples are collected at 7 set time points during one day

Study Arms (2)

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.

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.

Interventions

70% VO2max bike ergometer test for 90 minutes

Exercise day

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Magnesium DeficiencyMotor Activity

Condition Hierarchy (Ancestors)

Deficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesBehavior

Study Officials

  • Jacqueline Klein Gunnewiek, Phd

    Gelderse Vallei Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2015

First Posted

February 4, 2016

Study Start

December 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

February 4, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will share

Participants receive a letter with their personal information. VO2max, body weight and height, total Magnesium and ionized magnesium will be communicated.