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Aerobic Fitness in Overweight and Obese Individuals

A Randomized, Placebo-controlled, Multi-blind Study to Assess the Effect of Oxyjun on Aerobic Fitness in Overweight and Obese Individuals.

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03854786
Enrollment
11
Registered
2019-02-26
Start date
2020-01-03
Completion date
2020-05-28
Last updated
2021-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DIETARY_SUPPLEMENTOxyjun

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

DIETARY_SUPPLEMENTPacebo

Methyl Crystalline Cellulose

Sponsors

Vedic Lifesciences Pvt. Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 35 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
To investigate the effect on Oxyjun on aerobic fitness in overweight and obese individualsFrom baseline to Day 56Measured by change in VO2 max

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026