Aerobic Fitness in Overweight and Obese Individuals | NCT03854786

Studies
Aerobic Fitness in Overweight and Obese Individuals

NCT03854786

Sponsor

Vedic Lifesciences Pvt. Ltd.

Status

Terminated

Last Update Posted

Jan 19, 2021Actual

Enrollment

11Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Oxyjun
Pacebo

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to Covid - 19 pandemic

Expanded Access Info

Start Date

Jan 3, 2020Actual

Primary Completion Date

Mar 5, 2020Actual

Completion Date

May 28, 2020Actual

First Submitted Date

Feb 21, 2019

First Submission Date that Met QC Criteria

Feb 24, 2019

First Posted Date

Feb 26, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 13, 2021

Last Update Posted Date

Jan 19, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Oxyjun	Dietary Supplement	Oxyjun is the proprietary single ingredient product containing high concentrated well standardized aqueous extract of Terminalia arjuna.	Oxyjun

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vedic Lifesciences Pvt. Ltd		Mumbai	Opp Infinity Mall	400053	India

Intervention Browse Module

MeSH Terms

ID	Term
C113841	PACEBO protocol

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided