Aerobic Fitness in Overweight and Obese Individuals

NCT ID: NCT03854786

Last Updated: 2021-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-03

Study Completion Date

2020-05-28

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Oxyjun

Oxyjun- 400 mg OD after breakfast

Group Type ACTIVE_COMPARATOR

Oxyjun

Intervention Type DIETARY_SUPPLEMENT

Oxyjun is the proprietary single ingredient product containing high concentrated well standardized aqueous extract of Terminalia arjuna.

Methyl Crystalline Cellulose

Methyl Crystalline Cellulose- 400 mg OD after breakfast

Group Type PLACEBO_COMPARATOR

Pacebo

Intervention Type DIETARY_SUPPLEMENT

Methyl Crystalline Cellulose

Interventions

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Oxyjun

Oxyjun is the proprietary single ingredient product containing high concentrated well standardized aqueous extract of Terminalia arjuna.

Intervention Type DIETARY_SUPPLEMENT

Pacebo

Methyl Crystalline Cellulose

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Vedic Lifesciences Pvt. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Vedic Lifesciences Pvt. Ltd

Mumbai, Opp Infinity Mall, India

Site Status

Countries

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India

Other Identifiers

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EB/181201/OXYJUN/EVRG

Identifier Type: -

Identifier Source: org_study_id

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