NCT02374619

Brief Summary

Iron supplementation is very common in athletes, probably due to its catalytic role on the oxygen transport and optimal function of oxidative enzymes and proteins during exercise. Iron is also characterized as a potent pro-oxidant, as it can lead to increased production of reactive oxygen and nitrogen species (RONS) that are involved in critical biological processes, such as gene expression, signal transduction and enzyme activity. In exercise, low levels of RONS are essential for optimal force production, whereas excessive production of RONS can cause contractile dysfunction, resulting in muscle weakness and fatigue. On the other hand, RONS are involved in signaling pathways and up-regulation of the expression of several genes, and therefore, RONS can provoke favorable effects such as training adaptations. The purpose of the present study is to investigate the effect of iron supplementation on redox status, muscle damage and muscle performance after an acute bout of a valid muscle damaging eccentric exercise model in adults and children.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2011

Typical duration for not_applicable

Status
completed

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, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 2, 2015

Completed
Last Updated

April 14, 2015

Status Verified

April 1, 2015

Enrollment Period

1.8 years

First QC Date

February 16, 2015

Last Update Submit

April 12, 2015

Conditions

Keywords

eccentric exercisepro-oxidantsfree radicalsadultschildren

Outcome Measures

Primary Outcomes (6)

  • Changes in Maximum isometric torque (N.m)

    An isokinetic dynamometer (Cybex, Ronkonkoma, NY) will be used for the estimation of changes in isometric knee extensor's peak torque at 90o knee flexion between baseline and after 3 weeks of supplementation (pre-eccentric exercise), and also between pre-eccentric exercise and 24 hours, 48 hours, 72 hours, 96 hours after the eccentric exercise. The average of the three best maximal voluntary contractions with the subjects' one lower extremity will be recorded. To ensure that the subjects provide their maximal effort, the measurements will be repeated if the difference between the lower and the higher torque value exceed 10%. There will be two minutes rest between isometric efforts.

    Before the beginning of iron supplementation (baseline) at the end of the first supplementation period (3 weeks: pre-eccentric exercise), immediately after the eccentric exercise, and 24 hours, 48 hours, 72 hours, 96 hours after the eccentric exercise

  • Changes in Maximum concentric torque (N.m)

    An isokinetic dynamometer (Cybex, Ronkonkoma, NY) will be used for the estimation of changes in isokinetic knee extensor's peak torque at 60o/sec angular velocity between baseline and after 3 weeks of supplementation (pre-eccentric exercise), and also between pre-eccentric exercise and 24 hours, 48 hours, 72 hours, 96 hours after the eccentric exercise. The higher absolute value of five maximal voluntary contractions with the subjects' one lower extremity will be recorded.

    Before the beginning of iron supplementation (baseline) at the end of the first supplementation period (3 weeks: pre-eccentric exercise), immediately after the eccentric exercise, and 24 hours, 48 hours, 72 hours, 96 hours after the eccentric exercise

  • Changes in Maximum eccentric torque (N.m)

    An isokinetic dynamometer (Cybex, Ronkonkoma, NY) will be used for the estimation of changes in isokinetic knee extensor's peak torque at 60o/sec angular velocity between baseline and after 3 weeks of supplementation (pre-eccentric exercise), and also between pre-eccentric exercise and 24 hours, 48 hours, 72 hours, 96 hours after the eccentric exercise. The higher absolute value of five maximal voluntary contractions with the subjects' one lower extremity will be recorded.

    Before the beginning of iron supplementation (baseline) at the end of the first supplementation period (3 weeks: pre-eccentric exercise), immediately after the eccentric exercise, and 24 hours, 48 hours, 72 hours, 96 hours after the eccentric exercise

  • Changes in Range of motion, ROM (degrees)

    The assessment of changes in pain-free ROM between baseline and after 3 weeks of supplementation (pre-eccentric exercise), and also between pre-eccentric exercise and 24 hours, 48 hours, 72 hours, 96 hours after the eccentric exercise, will be performed manually using the isokinetic dynamometer. The investigator will move the calf at a very low angular velocity from 0 knee extension to the position where the subject will feel any discomfort.

    Before the beginning of iron supplementation (baseline) at the end of the first supplementation period (3 weeks: pre-eccentric exercise), immediately after the eccentric exercise, and 24 hours, 48 hours, 72 hours, 96 hours after the eccentric exercise

  • Changes in Delayed onset muscle soreness, DOMS (scale 1-10)

    Each participant will assess changes in delayed onset of muscle soreness (DOMS) during walking and squat movement (90o knee flexion) and perceived soreness between baseline and after 3 weeks of supplementation (pre-eccentric exercise), and also between pre-eccentric exercise and 24 hours, 48 hours, 72 hours, 96 hours after the eccentric exercise. DOMS and perceived soreness will be rated on a scale ranging from 1 (normal) to 10 (very sore).

    Before the beginning of iron supplementation (baseline) at the end of the first supplementation period (3 weeks: pre-eccentric exercise), immediately after the eccentric exercise, and 24 hours, 48 hours, 72 hours, 96 hours after the eccentric exercise

  • Changes in Creatine kinase, CK (activity IU)

    CK activity will be measured as a general indicator of muscle damage. Changes in CK activity between baseline and after 3 weeks of supplementation (pre-eccentric exercise), and also between pre-eccentric exercise and 24 hours, 48 hours, 72 hours, 96 hours after the eccentric exercise will be estimated in a Clinical Chemistry Analyzer Z1145 (Zafiropoulos Diagnostica, Athens, Greece) with commercially available kits (Zafiropoulos, Athens, Greece).

    Before the beginning of iron supplementation (baseline), at the end of the first supplementation period (3 weeks: pre exercise), and 72h after the eccentric exercise

Secondary Outcomes (12)

  • Changes in Reduced glutathione, GSH (μmol/g Hb)

    Adults: at baseline, pre-eccentric exercise, 24,48,72 & 96 hours after the eccentric exercise. Children: at baseline, pre-eccentric exercise and 72 hours after the eccentric exercise

  • Changes in Oxidized glutathione, GSSG (μmol/g Hb)

    Adults: at baseline, pre-eccentric exercise, 24,48,72 & 96 hours after the eccentric exercise. Children: at baseline, pre-eccentric exercise and 72 hours after the eccentric exercise

  • Changes in Thiobarbituric acid-reactive substances, TBARS (μM)

    Adults: at baseline, pre-eccentric exercise, 24,48,72 & 96 hours after the eccentric exercise. Children: at baseline, pre-eccentric exercise and 72 hours after the eccentric exercise

  • Changes in Protein carbonyls, PC (nmol/mg pr)

    Adults: at baseline, pre-eccentric exercise, 24,48,72 & 96 hours after the eccentric exercise. Children: at baseline, pre-eccentric exercise and 72 hours after the eccentric exercise

  • Changes in Catalase (μmol/min/mg Hb)

    Adults: at baseline, pre-eccentric exercise, 24,48,72 & 96 hours after the eccentric exercise. Children: at baseline, pre-eccentric exercise and 72 hours after the eccentric exercise

  • +7 more secondary outcomes

Study Arms (2)

Iron supplement

EXPERIMENTAL

Oral supplementation

Dietary Supplement: Iron supplement Resoferon Ferrous Sulfate

Control

PLACEBO COMPARATOR

Oral supplementation

Dietary Supplement: Placebo

Interventions

Oral supplementation with one tablet of iron supplement \[Resoferon Ferrous Sulfate 125 (37) mg\]

Iron supplement
PlaceboDIETARY_SUPPLEMENT
Control

Eligibility Criteria

Age10 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Physiological body mass index (BMI).
  • Physiological health profile.
  • Subject provides written informed consent.

You may not qualify if:

  • Professional athlete.
  • Consumed any nutritional supplement the last 3 months.
  • Performed pure eccentric exercise the last 6 months.
  • Non Caucasian.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Theodorou AA, Nikolaidis MG, Paschalis V, Koutsias S, Panayiotou G, Fatouros IG, Koutedakis Y, Jamurtas AZ. No effect of antioxidant supplementation on muscle performance and blood redox status adaptations to eccentric training. Am J Clin Nutr. 2011 Jun;93(6):1373-83. doi: 10.3945/ajcn.110.009266. Epub 2011 Apr 20.

    PMID: 21508092BACKGROUND
  • Gomez-Cabrera MC, Martinez A, Santangelo G, Pallardo FV, Sastre J, Vina J. Oxidative stress in marathon runners: interest of antioxidant supplementation. Br J Nutr. 2006 Aug;96 Suppl 1:S31-3. doi: 10.1079/bjn20061696.

    PMID: 16923247BACKGROUND
  • Deli CK, Fatouros IG, Paschalis V, Tsiokanos A, Georgakouli K, Zalavras A, Avloniti A, Koutedakis Y, Jamurtas AZ. Iron Supplementation Effects on Redox Status following Aseptic Skeletal Muscle Trauma in Adults and Children. Oxid Med Cell Longev. 2017;2017:4120421. doi: 10.1155/2017/4120421. Epub 2017 Jan 22.

Study Officials

  • Athanasios Z Jamurtas, Dr

    University of Thessaly

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 16, 2015

First Posted

March 2, 2015

Study Start

December 1, 2011

Primary Completion

October 1, 2013

Study Completion

December 1, 2013

Last Updated

April 14, 2015

Record last verified: 2015-04