Aerobic Fitness in Overweight and Obese Individuals

Not Applicable

Terminated

• Conditions: Healthy
• Interventions: Dietary Supplement: Pacebo; Dietary Supplement: Oxyjun

• Registration Number: NCT03854786
• Lead Sponsor: Vedic Lifesciences Pvt. Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-21
• Study First Submitted QC: 2019-02-24
• Study First Posted: 2019-02-26
• Status Verified: 2020-01
• Study Start: 2020-01-03
• Primary Completion: 2020-03-05
• Study Completion: 2020-05-28
• Last Update Submitted: 2021-01-13
• Last Update Posted: 2021-01-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methyl Crystalline Cellulose	Pacebo	Methyl Crystalline Cellulose- 400 mg OD after breakfast
Oxyjun	Oxyjun	Oxyjun- 400 mg OD after breakfast

Primary Outcome Measures

Name	Time	Method
To investigate the effect on Oxyjun on aerobic fitness in overweight and obese individuals	From baseline to Day 56	Measured by change in VO2 max

Trial Locations

Locations (1)

Vedic Lifesciences Pvt. Ltd; 🇮🇳 Mumbai, Opp Infinity Mall, India