- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03854786
Aerobic Fitness in Overweight and Obese Individuals
A Randomized, Placebo-controlled, Multi-blind Study to Assess the Effect of Oxyjun on Aerobic Fitness in Overweight and Obese Individuals.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Opp Infinity Mall
-
Mumbai, Opp Infinity Mall, India, 400053
- Vedic Lifesciences Pvt. Ltd
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Oxyjun
Oxyjun- 400 mg OD after breakfast
|
Oxyjun is the proprietary single ingredient product containing high concentrated well standardized aqueous extract of Terminalia arjuna.
|
Placebo Comparator: Methyl Crystalline Cellulose
Methyl Crystalline Cellulose- 400 mg OD after breakfast
|
Methyl Crystalline Cellulose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To investigate the effect on Oxyjun on aerobic fitness in overweight and obese individuals
Time Frame: From baseline to Day 56
|
Measured by change in VO2 max
|
From baseline to Day 56
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EB/181201/OXYJUN/EVRG
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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