Aerobic Fitness in Overweight and Obese Individuals

January 13, 2021 updated by: Vedic Lifesciences Pvt. Ltd.

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

Terminated

Conditions

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Opp Infinity Mall
      • Mumbai, Opp Infinity Mall, India, 400053
        • Vedic Lifesciences Pvt. Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2020

Primary Completion (Actual)

March 5, 2020

Study Completion (Actual)

May 28, 2020

Study Registration Dates

First Submitted

February 21, 2019

First Submitted That Met QC Criteria

February 24, 2019

First Posted (Actual)

February 26, 2019

Study Record Updates

Last Update Posted (Actual)

January 19, 2021

Last Update Submitted That Met QC Criteria

January 13, 2021

Last Verified

January 1, 2020

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

No

Studies a U.S. FDA-regulated device product

No

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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