A Study to Evaluate the Efficacy of OxyjunTM on Cardiac Pumping Capacity as Well as Work Productivity in Individuals With Metabolic Risk.
NCT Number: NCT06496880
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Metabolic Disorder
Interventions: DIETARY_SUPPLEMENT: Oxyjun TM|DIETARY_SUPPLEMENT: Placebo
Sponsor: Vedic Lifesciences Pvt. Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 64
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-07-15
Completion Date: 2024-12-30
Locations: Sigma Hospital, Mumbai, Maharashtra, 400080, India|Vedant Multispeciality Hospital, Pune, Maharashtra, 411019, India|Umarji Mother & Child Care Hospital, Pune, Maharashtra, 411045, India|Swara Hospital, Thane, Maharashtra, 401303, India|Silver Birch Multispecialty Hospital, Pune, Maharshtra, India|Medical Care Centre and Hospital, Lucknow, Uttar Pradesh, 226005, India|Upendra Medicare Hospital, Varanasi, Uttar Pradesh, 221001, India|Janta hospital & Maternity Centre, Varanasi, Uttar Pradesh, 221011., India

Summary:
A Randomized, Double Blind, Placebo-controlled, Parallel Group Study to Evaluate Efficacy of OxyjunTM on Cardiac Pumping Capacity as well as Work Productivity in Individuals with Metabolic Risk.

Primary Outcome Measures: To evaluate the effect of 8-week oral consumption of OxyjunTM on left ventricular function as evaluated by Left ventricle ejection fraction (LVEF)., LVEF is the fraction of chamber volume ejected during systole (stroke volume or SV) in relation to the volume of blood in the ventricle at the end of diastole (end-diastolic volume or EDV). The LVEF will be assessed by using M-mode 2D Echo.

LVEF is calculated using the formula- LVEF: \[SV/EDV\] x 100, Screening|To evaluate the effect of 8-week oral consumption of OxyjunTM on left ventricular function as evaluated by Left ventricle ejection fraction (LVEF)., LVEF is the fraction of chamber volume ejected during systole (stroke volume or SV) in relation to the volume of blood in the ventricle at the end of diastole (end-diastolic volume or EDV). The LVEF will be assessed by using M-mode 2D Echo.

LVEF is calculated using the formula- LVEF: \[SV/EDV\] x 100, Day 28|To evaluate the effect of 8-week oral consumption of OxyjunTM on left ventricular function as evaluated by Left ventricle ejection fraction (LVEF)., LVEF is the fraction of chamber volume ejected during systole (stroke volume or SV) in relation to the volume of blood in the ventricle at the end of diastole (end-diastolic volume or EDV). The LVEF will be assessed by using M-mode 2D Echo.

LVEF is calculated using the formula- LVEF: \[SV/EDV\] x 100, Day 56
Secondary Outcome Measures: To evaluate the effect of 8-week oral consumption of Oxyjun TM on Cardiac pumping capacity as evaluated by the ventricular stroke volume and cardiac output., Cardiac output is determined by multiplying heart rate and stroke volume and is typically measured in liters per minute cardiac output is expressed as CO = HR × SV.

The normal range for stroke volume is typically 55-100 mL. An average resting heart rate is approximately 75 beats per minute (bpm), but it can vary between 60-100 bpm in some individuals.

The normal cardiac output falls within the range of 4.0-6.0 L/min at rest, Screening, Day 28 and Day 56|To evaluate the effect of 8-week oral consumption of Oxyjun TM on Responder to the product as assessed by the number of the participant having LVEF more than equal to 5 units increase., Echocardiography define normal left ventricular ejection fraction (LVEF) as greater than 50% and greater than 55%, respectively., Screening, Day 28 and Day 56|To evaluate the effect of 8-week oral consumption of OxyjunTM on Work Productivity as assessed by the Work Productivity and Activity Impairment Questionnaire, The Work Productivity and Activity Impairment (WPAI) questionnaire stands as a thoroughly validated tool designed to assess impairments in both work-related tasks and general activities.

In this study, a 10 point Visual Analogue scale is used to evaluate how health problems affect the participant's ability to do their regular activity where 0 means no effect and 10 means complete hinderance in daily activities., Day 0, Day 28 and Day 56|To evaluate the effect of 8-week oral consumption of Oxyjun TM on Cardiac risk as assessed by the N-terminal pro b-type natriuretic peptide (NT-Pro BNP), NT-Pro BNP levels have been noted in various cardiovascular conditions, encompassing chronic heart failure and left ventricular dysfunction.

Normal reference range considered in this study for males and females for NT-Pro BNP is \<125 pg/ml, Day 0 and Day 56|To evaluate the effect of 8-week oral consumption of Oxyjun TM on Physical activity as assessed by IPAQ-SF questionnaire, The IPAQ-SF is a standardized and culturally adaptable tool to assess habitual physical activity in individuals across the globe.

Scoring a HIGH level of physical activity on the IPAQ-SF means the physical activity levels equate to approximately one hour of activity per day or more at least a moderate intensity activity level.

Scoring a MODERATE level of physical activity on the IPAQ-SF means one is doing some activity more than likely equivalent to half an hour of at least moderate intensity physical activity on most days.

Scoring a LOW level of physical activity on the IPAQ-SF means that the participant is not meeting any of the criteria for either MODERATE or HIGH levels of physical activity., Day 0, day 28 and day 56