A Study to Evaluate the Efficacy of OxyjunTM on Cardiac Pumping Capacity as Well as Work Productivity in Individuals With Metabolic Risk.

NCT06496880 | Completed

• 1 other identifier: EB/240301/OXY/CPC
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Metabolic Disorder

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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.

  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.

  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

  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)

  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

  Day 0, day 28 and day 56

Study Arms (2)

OxyjunTM

ACTIVE COMPARATOR

One capsule daily to be taken after breakfast for 56 days

Dietary Supplement: Oxyjun TM

Microcrystalline Cellulose

PLACEBO COMPARATOR

One capsule daily to be taken after breakfast for 56 days

Dietary Supplement: Placebo

Interventions

Oxyjun TM DIETARY_SUPPLEMENT

One capsule daily to be taken after breakfast for 56 days

OxyjunTM

Placebo DIETARY_SUPPLEMENT

One capsule daily to be taken after breakfast for 56 days

Microcrystalline Cellulose

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals of either sex, aged more than equal to 45 to less than equal to 70 years at the time of screening with BMI more than equal to 25 kg/metre square to less than equal to 34.9 kg/metre square.
• Individuals with normal to high blood pressure (BP) \[systolic BP more than equal to 120 mmHg and less than equal to 159 mmHg and/or diastolic BP more than equal to 80 mmHg and less than equal to 89 mmHg\].
• Individuals with waist circumference more than equal to 40 inches for men or 35 inches for women.
• Individuals with normal to mildly deranged 'Left ventricular ejection' as per American College of Cardiology: LVEF more than equal to 45% and less than equal to 55%.
• Fasting glucose level of more than equal to 110 mg/dL and less than equal to 160 mg/dL (without medication or with maximum 500 mg of daily dose of Metformin).
• Individuals with Aspartate aminotransaminase (AST) and Alanine transaminase (ALT) within 2 times upper normal limit (ULN).
• Individuals with 1.5 x Upper Normal Limit (ULN) of Creatinine.
• Individuals having following values of haemoglobin:
• Female - more than equal to 11 mg/dl
• Male - more than equal to 12 mg/dl
• Individuals with thyroid stimulating hormone (TSH) levels in between 0.27 IU/ml and 5 IU/ml both values included.
• Individuals who demonstrate their willingness to participate in the study and comply with the study procedures and required visits.
• Willing to abstain from caffeine for 12 hours prior to the visit
• Willing to abstain from alcohol and related products consumption for 48 hours prior to study visits
• Must be literate, having the ability to understand, complete the study-based questionnaires, requirements and sign a written informed consent form, which must be completed prior to study specific requirements being performed.

You may not qualify if:

• History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic or neurologic disorders that, in the judgement of the investigator, would interfere with the individuals ability to provide informed consent, comply with the study protocol, or put the individual at undue risk.
• Using Omega fish oil supplements, anticonvulsants, Coenzyme Q10, Vitamin K2, proton pump inhibitors, loop diuretics, anticoagulants, barbiturates, anti-epileptic medications and any herbal supplements (e.g. flax seeds, chia seeds).
• Chronic use of anti-inflammatory medications (more than equal to 5 tablets/20 days in last 3 months).
• Individuals having a history of smoking or currently smoking or using any form of smokeless tobacco.
• High-risk drinking as defined by consumption of 4 or more drinks of alcohol containing beverages on any day or 10 or more drinks of alcohol containing beverages per week for women and 5 or more drinks of alcohol containing beverages on any day or 14 or more drinks of alcohol containing beverages per week for men.
• Individuals unable to walk. Individuals with a history of chronic caffeine use with more than 3 cups of caffeinated beverage/ day.
• Individuals who have any other disease or condition, or are using any medication, that in the judgment of the investigator would put him/her at unacceptable risk for participation in the study or may interfere with evaluations in the study or noncompliance with treatment or visits.
• Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
• Females undergoing hormone replacement treatments.
• Peri- or post-menopausal females having less than equal to 1 year of irregular or complete absence of menstrual cycle.
• Those unwilling to abstain from other dietary supplements or medication (e.g. Hepatoprotective agents and complementary and alternative medicine).
• Have participated in a study of an investigational product 90 days prior to the screening.
• Individuals with known or suspected hypersensitivity or intolerance to Investigational product.
• Individuals who are unable to comply with study requirements.
• Individuals with a history of autoimmune disorders

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (7)

Sigma Hospital

Mumbai, Maharashtra, 400080, India

Location

Vedant Multispeciality Hospital

Pune, Maharashtra, 411019, India

Location

Umarji Mother & Child Care Hospital

Pune, Maharashtra, 411045, India

Location

Swara Hospital

Thane, Maharashtra, 401303, India

Location

Silver Birch Multispecialty Hospital

Pune, Maharshtra, India

Location

Upendra Medicare Hospital

Varanasi, Uttar Pradesh, 221001, India

Location

Janta hospital & Maternity Centre

Varanasi, Uttar Pradesh, 221011., India

Location

MeSH Terms

Conditions

Metabolic Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

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

Model Details: Randomized, Double Blind, Placebo-controlled, Parallel Group

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 11, 2024
• Study Start: September 10, 2024
• Primary Completion: February 17, 2025
• Study Completion: February 17, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

IN (7)