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Aerobic Fitness in Overweight and Obese Individuals

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
Sponsor:
Information provided by (Responsible Party):
Vedic Lifesciences Pvt. Ltd.

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Oxyjun Dietary Supplement: Pacebo Not Applicable

Study Design
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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
Arms and Interventions
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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
 Dietary Supplement: Pacebo
Methyl Crystalline Cellulose


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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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
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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India
Vedic Lifesciences Pvt. Ltd
Mumbai, Opp Infinity Mall, India, 400053
Sponsors and Collaborators
Vedic Lifesciences Pvt. Ltd.
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Body Weight