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Study to Assess the Effect of OXYJUN on Ejection Fraction and Markers of Cardiovascular Injury

NCT02207101 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2015-07-10

No results posted yet for this study

Summary

Young athletes are usually regarded as a special subgroup of healthy individuals with a unique lifestyle who are apparently invulnerable and often capable of extraordinary physical achievement. Most athletic disciplines to some extent combine endurance and strength modes of physical conditioning. Acute responses to endurance exercise training include substantial increases in maximal oxygen uptake, cardiac output, stroke volume, and systolic blood pressure in-spite of this, high intensity chronic training such as marathons, very long distance bicycle racing etc., can lead to transient acute volume overload of the atria and right ventricle, with transient reductions in right ventricular ejection fraction and elevations of cardiac biomarkers. Although these biomarkers generally normalize back within seven to ten days, these transient changes may sooner or later mark the beginning of processes like patchy myocardial fibrosis finally leading to grave chronic heart diseases .

Inspite of the awareness regarding the cardio vascular risk in the athletes, there have been no new advancements in finding an alternate option which can protect the cardio vascular system in the athletes.

Hence in order to address the need of the hour and also to avoid the cardio vascular risk in athletes along with improvising the endurance capacity, Enovate Biolife is in the process of development of an innovative product "E-OJ-01".

E-OJ-01 is expected to have beneficial effects on the cardio vascular system of the athletes by enhancing ejection fraction which in turn improves cardiac output. This finally is hypothysed to increase the maximal oxygen uptake capacity in athletes.

Conditions

  • Cardiac Function in Young Athletes

Interventions

DIETARY_SUPPLEMENT

E-OJ-01 (OXYJUN)

DIETARY_SUPPLEMENT

Placebo

Sponsors & Collaborators

  • Enovate Biolife Pvt Ltd

    collaborator INDUSTRY

  • Vedic Lifesciences Pvt. Ltd.

    lead INDUSTRY

Principal Investigators

  • Ravi Chavan, MD

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02207101 on ClinicalTrials.gov