Aerobic Fitness in Overweight and Obese Individuals
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03854786 |
Recruitment Status :
Terminated
(Due to Covid - 19 pandemic)
First Posted : February 26, 2019
Last Update Posted : January 19, 2021
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Dietary Supplement: Oxyjun Dietary Supplement: Pacebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 11 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Other |
Official Title: | A Randomized, Placebo-controlled, Multi-blind Study to Assess the Effect of Oxyjun on Aerobic Fitness in Overweight and Obese Individuals. |
Actual Study Start Date : | January 3, 2020 |
Actual Primary Completion Date : | March 5, 2020 |
Actual Study Completion Date : | May 28, 2020 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Oxyjun
Oxyjun- 400 mg OD after breakfast
|
Dietary Supplement: Oxyjun
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
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Dietary Supplement: Pacebo
Methyl Crystalline Cellulose |
- 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

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Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
Sexes Eligible for Study: | Male |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | Yes |
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.

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): NCT03854786
India | |
Vedic Lifesciences Pvt. Ltd | |
Mumbai, Opp Infinity Mall, India, 400053 |
Responsible Party: | Vedic Lifesciences Pvt. Ltd. |
ClinicalTrials.gov Identifier: | NCT03854786 |
Other Study ID Numbers: |
EB/181201/OXYJUN/EVRG |
First Posted: | February 26, 2019 Key Record Dates |
Last Update Posted: | January 19, 2021 |
Last Verified: | January 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Overweight Body Weight |