Study to Assess the Effect of OXYJUN on Ejection Fraction and Markers of Cardiovascular Injury (Enduoxy)
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|ClinicalTrials.gov Identifier: NCT02207101|
Recruitment Status : Completed
First Posted : August 1, 2014
Last Update Posted : July 10, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Function in Young Athletes||Dietary Supplement: E-OJ-01 (OXYJUN) Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Health Services Research|
|Official Title:||The Effect of Investigational Product E-OJ-01 (OXYJUN) on Left Ventricular Ejection Fraction and Markers of Cardiovascular Injury.|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Active Comparator: E-OJ-01 (OXYJUN)
E-OJ-01 (OXYJUN). Dose: 01 capsule to be taken orally daily after lunch.
Dietary Supplement: E-OJ-01 (OXYJUN)
Placebo Comparator: Placebo
Matching placebo capsules [for E-OJ-01 (OXYJUN)] composed of microcrystalline cellulose. Dose: 01 capsule to be taken orally daily after lunch.
Dietary Supplement: Placebo
- Change in Left Ventricular Ejection Fraction [ Time Frame: Day 0, Day 28 and Day 56 ]
- Change in Serum Troponin-T [ Time Frame: Day 0 and Day 56 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02207101
|Mumbai, Maharashtra, India, 400053|
|Principal Investigator:||Ravi Chavan, MD|