NCT01290458

Brief Summary

Consumption of vitamin supplements is a common practice among athletes or people participating in health promoting exercise programs. The reason for this interest in vitamin supplements is primarily because of the observation that enhanced production of reactive oxygen and nitrogen species (RONS) influence fundamental biological processes, such as gene expression, signal transduction and enzyme activity. In a muscle and exercise physiology context, a low level of RONS is required for normal force production, whereas marked increases in RONS can cause contractile dysfunction, resulting in muscle weakness and fatigue. On the other hand RONS are involved in signaling pathways and serve to up-regulate the expression of a number of genes and can exert favorable effects such as training adaptations. The present study will employ a valid eccentric exercise model to examine the influence of combined vitamin C and E supplementation after acute and chronic eccentric exercise on muscle damage and performance, redox status, hemolysis and lipid and lipoprotein profile.

Trial Health

87
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 Jun 2009

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 7, 2011

Completed
Last Updated

February 7, 2011

Status Verified

January 1, 2011

Enrollment Period

5 months

First QC Date

February 4, 2011

Last Update Submit

February 4, 2011

Conditions

Keywords

Eccentric trainingFree radicalsAntioxidant supplementsTraining adaptationsLipid profile

Outcome Measures

Primary Outcomes (4)

  • Maximum isometric torque (torque)

    An isokinetic dynamometer (Cybex, Ronkonkoma, NY) will be used for the measurement of isometric knee extensor peak torque at 90° knee flexion. The average of the three best maximal voluntary contractions with their dominant leg will be recorded. In order 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 exceeded 10%. There will be two minutes rest between isometric efforts.

    Before the beginning of the supplementation (week 0), the week after the first bout of eccentric exercise (week 5), and the week after the second bout of eccentric exercise (week 11)

  • Range of motion, ROM (degrees)

    The assessment of pain-free ROM will be performed manually using the 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 the supplementation (week 0), the week after the first bout of eccentric exercise (week 5), and the week after the second bout of eccentric exercise (week 11)

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

    Each participant will assess delayed onset muscle soreness (DOMS) during squat movement (90o knee flexion) and perceived soreness will be rated on a scale ranging from 1 (normal) to 10 (very sore).

    Before the beginning of the supplementation (week 0), the week after the first bout of eccentric exercise (week 5), and the week after the second bout of eccentric exercise (week 11)

  • Creatine kinase, CK (activity IU)

    CK activity will be measured as a general indicator of muscle damage.It will be measured in a Cobas Integra Plus 400 chemistry analyzer. CK will be measured before the beginning of the supplementation (week 0), before and the week after the first bout of eccentric exercise (week 5), before and the week after the second bout of eccentric exercise (week 11).

    Before the beginning of the supplementation (week 0), the week after the first bout of eccentric exercise (week 5), and the week after the second bout of eccentric exercise (week 11)

Secondary Outcomes (15)

  • Reduced glutathione, GSH (μmol/g Hb)

    Before the beginning of the supplementation (week 0), the week after the first bout of eccentric exercise (week 5), and the week after the second bout of eccentric exercise (week 11)

  • Oxidized glutathione, GSSG (μmol/g Hb)

    Before the beginning of the supplementation (week 0), the week after the first bout of eccentric exercise (week 5), and the week after the second bout of eccentric exercise (week 11)

  • Thiobarbituric acid-reactive substances, TBARS (μM)

    Before the beginning of the supplementation (week 0), the week after the first bout of eccentric exercise (week 5), and the week after the second bout of eccentric exercise (week 11)

  • Protein carbonyls (nmol/mg pr.)

    Before the beginning of the supplementation (week 0), the week after the first bout of eccentric exercise (week 5), and the week after the second bout of eccentric exercise (week 11)

  • Catalase (μmol/min/mg Hb)

    Before the beginning of the supplementation (week 0), the week after the first bout of eccentric exercise (week 5), and the week after the second bout of eccentric exercise (week 11)

  • +10 more secondary outcomes

Study Arms (2)

Vitamin

EXPERIMENTAL
Dietary Supplement: Antioxidant vitamins

Control

PLACEBO COMPARATOR
Dietary Supplement: Antioxidant vitamins

Interventions

Antioxidant vitaminsDIETARY_SUPPLEMENT

Oral supplementation with one tablet of 1 g of vitamin C (Lamberts Healthcare Ltd, UK) and one tablet of 400 IU of vitamin E (Lamberts Healthcare Ltd, UK)

Also known as: For vitamin C ascorbic acid, For vitamin E d-alpha tocopherol
ControlVitamin

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Smoker
  • 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

Study Sites (1)

University of Thessaly

Trikala, 42100, Greece

Location

Related Publications (3)

  • Paschalis V, Nikolaidis MG, Theodorou AA, Panayiotou G, Fatouros IG, Koutedakis Y, Jamurtas AZ. A weekly bout of eccentric exercise is sufficient to induce health-promoting effects. Med Sci Sports Exerc. 2011 Jan;43(1):64-73. doi: 10.1249/MSS.0b013e3181e91d90.

    PMID: 20508540BACKGROUND
  • Paschalis V, Nikolaidis MG, Giakas G, Theodorou AA, Sakellariou GK, Fatouros IG, Koutedakis Y, Jamurtas AZ. Beneficial changes in energy expenditure and lipid profile after eccentric exercise in overweight and lean women. Scand J Med Sci Sports. 2010 Feb;20(1):e103-11. doi: 10.1111/j.1600-0838.2009.00920.x. Epub 2009 Apr 14.

    PMID: 19422638BACKGROUND
  • Nikolaidis MG, Paschalis V, Giakas G, Fatouros IG, Sakellariou GK, Theodorou AA, Koutedakis Y, Jamurtas AZ. Favorable and prolonged changes in blood lipid profile after muscle-damaging exercise. Med Sci Sports Exerc. 2008 Aug;40(8):1483-9. doi: 10.1249/MSS.0b013e31817356f2.

    PMID: 18614942BACKGROUND

MeSH Terms

Conditions

Hemolysis

Interventions

Ascorbic Acidalpha-Tocopherol

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydratesTocopherolsVitamin EBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Athanasios Z Jamurtas, Dr

    University of Thessaly

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 4, 2011

First Posted

February 7, 2011

Study Start

June 1, 2009

Primary Completion

November 1, 2009

Study Completion

June 1, 2010

Last Updated

February 7, 2011

Record last verified: 2011-01

Locations