NCT03854786

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 26, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

January 3, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2020

Completed
Last Updated

January 19, 2021

Status Verified

January 1, 2020

Enrollment Period

2 months

First QC Date

February 21, 2019

Last Update Submit

January 13, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • To investigate the effect on Oxyjun on aerobic fitness in overweight and obese individuals

    Measured by change in VO2 max

    From baseline to Day 56

Study Arms (2)

Oxyjun

ACTIVE COMPARATOR

Oxyjun- 400 mg OD after breakfast

Dietary Supplement: Oxyjun

Methyl Crystalline Cellulose

PLACEBO COMPARATOR

Methyl Crystalline Cellulose- 400 mg OD after breakfast

Dietary Supplement: Pacebo

Interventions

OxyjunDIETARY_SUPPLEMENT

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

Oxyjun
PaceboDIETARY_SUPPLEMENT

Methyl Crystalline Cellulose

Methyl Crystalline Cellulose

Eligibility Criteria

Age18 Years - 35 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vedic Lifesciences Pvt. Ltd

Mumbai, Opp Infinity Mall, 400053, India

Location

MeSH Terms

Interventions

PACEBO protocol

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2019

First Posted

February 26, 2019

Study Start

January 3, 2020

Primary Completion

March 5, 2020

Study Completion

May 28, 2020

Last Updated

January 19, 2021

Record last verified: 2020-01

Locations

IN(1)