NCT01296490

Brief Summary

Physical exercise has many benefits, although it might also have negative impact on the body, which changes in accordance with training level, length of workout, age of subject and their fitness level. These outcomes are governed by complex biological processes, from which Reactive Oxygen Substances (ROS) are considered the most prominent ones during exercise activity. These substances harm muscle activity, and might cause other health related damage by influencing other pathways that engage with free radicals. Excess of ROS, is expressed as Oxidative Stress (OS), pathogenic process activation and aging. With this in mind, it is important to remember that ROS are essential to the investigators bodies as well, especially in gene regulation. Thus they influence proteins that are important for proper muscle function and the immune system. Physical exercise induces changes in low molecular weight antioxidants, and in antioxidant enzymes. According to results that were published in the literature, no universal conclusion can be made regarding physical exercise effect on antioxidants activity. These contradictions might be attributed to the difference between the methods that were used, and their quality. Paradoxically, physical exercise has the same effect on ROS inducement in skeletal muscle fibers as does not using the muscles for a long period of time (especially as a result of handicap). It is well known that physical exercise effect oxidative stress and antioxidant. Due to the doubts that rise from the literature, the investigators think that it is important to test physical fitness effect on oxidative stress biological markers, using various high quality methods, on the same population. The investigators will test healthy men, 20-35 years of age, none smokers with 6-24% fat, who do not take vitamins or supplements. The men will run on a treadmill for 10 minutes to exhaustion, and blood will be taken before the test, 5 minutes after the test, and an hour after the test (checking recovery).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2011

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 15, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

January 1, 2014

Status Verified

December 1, 2013

Enrollment Period

11 months

First QC Date

February 3, 2011

Last Update Submit

December 31, 2013

Conditions

Keywords

oxidative stress, physical exercise, fitness level

Outcome Measures

Primary Outcomes (1)

  • Higher increase in oxidative stress inducing factors, and antioxidants in men with lower physical fitness compared with men with higher physical fitness.

    one year

Study Arms (1)

Stress test

EXPERIMENTAL

The men will run on a treadmill for 10 minutes until exhaustion. Blood will be drawn before, 5 minutes after and an hour after the test.

Other: Stress test

Interventions

Stress test while running on a treadmill until exhaustion for 8-12 minutes. Blood will be drawn before, 5 minutes after and an hour after the test.

Also known as: blood test
Stress test

Eligibility Criteria

Age20 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men
  • years of age, with 6-24% body fat.

You may not qualify if:

  • Smokers and subjects who use vitamins and supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wingate Institute

Netanya, 42902, Israel

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise TestHematologic Tests

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative TechniquesClinical Laboratory Techniques

Study Officials

  • Dov Lichtenberg, PhD

    Tel Aviv University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Sports medicine and research center

Study Record Dates

First Submitted

February 3, 2011

First Posted

February 15, 2011

Study Start

June 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

January 1, 2014

Record last verified: 2013-12

Locations