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Aerobic Fitness in Overweight and Obese Individuals

Primary Purpose

Healthy

Status
Terminated
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Oxyjun
Pacebo
Sponsored by
Vedic Lifesciences Pvt. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Healthy

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Vedic Lifesciences Pvt. Ltd

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Oxyjun

Methyl Crystalline Cellulose

Arm Description

Oxyjun- 400 mg OD after breakfast

Methyl Crystalline Cellulose- 400 mg OD after breakfast

Outcomes

Primary Outcome Measures

To investigate the effect on Oxyjun on aerobic fitness in overweight and obese individuals
Measured by change in VO2 max

Secondary Outcome Measures

Full Information

First Posted
February 21, 2019
Last Updated
January 13, 2021
Sponsor
Vedic Lifesciences Pvt. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03854786
Brief Title
Aerobic Fitness in Overweight and Obese Individuals
Official Title
A Randomized, Placebo-controlled, Multi-blind Study to Assess the Effect of Oxyjun on Aerobic Fitness in Overweight and Obese Individuals.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
Due to Covid - 19 pandemic
Study Start Date
January 3, 2020 (Actual)
Primary Completion Date
March 5, 2020 (Actual)
Study Completion Date
May 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vedic Lifesciences Pvt. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxyjun
Arm Type
Active Comparator
Arm Description
Oxyjun- 400 mg OD after breakfast
Arm Title
Methyl Crystalline Cellulose
Arm Type
Placebo Comparator
Arm Description
Methyl Crystalline Cellulose- 400 mg OD after breakfast
Intervention Type
Dietary Supplement
Intervention Name(s)
Oxyjun
Intervention Description
Oxyjun is the proprietary single ingredient product containing high concentrated well standardized aqueous extract of Terminalia arjuna.
Intervention Type
Dietary Supplement
Intervention Name(s)
Pacebo
Intervention Description
Methyl Crystalline Cellulose
Primary Outcome Measure Information:
Title
To investigate the effect on Oxyjun on aerobic fitness in overweight and obese individuals
Description
Measured by change in VO2 max
Time Frame
From baseline to Day 56

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Vedic Lifesciences Pvt. Ltd
City
Mumbai
State/Province
Opp Infinity Mall
ZIP/Postal Code
400053
Country
India

12. IPD Sharing Statement

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Aerobic Fitness in Overweight and Obese Individuals

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