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NCT03854786 Clinical Trial

Aerobic Fitness in Overweight and Obese Individuals

Healthy Clinical Trial

Official title:
A Randomized, Placebo-controlled, Multi-blind Study to Assess the Effect of Oxyjun on Aerobic Fitness in Overweight and Obese Individuals.

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03854786
Other study ID # EB/181201/OXYJUN/EVRG
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date January 3, 2020
Est. completion date May 28, 2020

Study information
Verified date January 2020
Source Vedic Lifesciences Pvt. Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Oxyjun is known for improving cardiovascular endurance. Overweight and obese individuals are at increased risk of cardiovascular complications. To lower the risk, these individuals need to remain physically active with acceptable aerobic fitness. Hence, the objective of the study is to investigate the effect of Oxyjun on aerobic fitness in physically active overweight and obese individuals. All subjects in the study will be tested for maximum aerobic capacity , body composition, and serum biomarker for fitness.

Recruitment information / eligibility
Status Terminated
Enrollment 11
Est. completion date May 28, 2020
Est. primary completion date March 5, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Body Mass Index = 25 - = 34.9 kg/m2. - Waist Circumference = 80 cms. - Non-smoker. - BP = 140/90 mm Hg - FBS = 125 mg/dl - Hb = 11 g/ dl - Can abstain from strenuous exercise and alcohol for at least 48 hours. - Can abstain from caffeine for at least 24 hours. Exclusion Criteria: - Participants with history of regular (=2 times a week) structured exercise (gym, walking, yoga, etc). - Inter-arm blood pressure is =10 mm Hg. - Known cases of type II Diabetes Mellitus. - Known cases of hypertension with or without anti-hypertensive medication. - Visual or balance problems, or who cannot walk on a treadmill without using the handrails.

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Oxyjun
Oxyjun is the proprietary single ingredient product containing high concentrated well standardized aqueous extract of Terminalia arjuna.
• Pacebo
Methyl Crystalline Cellulose

Locations
Country Name City State
India Vedic Lifesciences Pvt. Ltd Mumbai Opp Infinity Mall

Sponsors (1)
Lead Sponsor Collaborator
Vedic Lifesciences Pvt. Ltd.

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary To investigate the effect on Oxyjun on aerobic fitness in overweight and obese individuals Measured by change in VO2 max From baseline to Day 56
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