Clinical trial NCT06496880: A Study to Evaluate the Efficacy of OxyjunTM on Cardiac Pumping Capacity as Well as Work Productivity in Individuals With Metabolic Risk.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Disorder
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2024-07-11
Enrollment: 64
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Double Blind, Placebo-controlled, Parallel Group
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* 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:

  1. Female - more than equal to 11 mg/dl
  2. 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.

Exclusion Criteria:

* 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
* Individuals with a history of immunocompromised status
* Any clinical signs or symptoms that in the opinion of the investigator can jeopardize the outcome of the study.

Primary outcomes:
measure: To evaluate the effect of 8-week oral consumption of OxyjunTM on left ventricular function as evaluated by Left ventricle ejection fraction (LVEF).
timeFrame: Screening
measure: To evaluate the effect of 8-week oral consumption of OxyjunTM on left ventricular function as evaluated by Left ventricle ejection fraction (LVEF).
timeFrame: Day 28
measure: To evaluate the effect of 8-week oral consumption of OxyjunTM on left ventricular function as evaluated by Left ventricle ejection fraction (LVEF).
timeFrame: Day 56
Secondary outcomes:
measure: 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.
timeFrame: Screening, Day 28 and Day 56
measure: 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.
timeFrame: Screening, Day 28 and Day 56
measure: To evaluate the effect of 8-week oral consumption of OxyjunTM on Work Productivity as assessed by the Work Productivity and Activity Impairment Questionnaire
timeFrame: Day 0, Day 28 and Day 56
measure: 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)
timeFrame: Day 0 and Day 56
measure: To evaluate the effect of 8-week oral consumption of Oxyjun TM on Physical activity as assessed by IPAQ-SF questionnaire
timeFrame: Day 0, day 28 and day 56
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Sigma Hospital
state: Maharashtra
city: Pune
country: India
facility: Vedant Multispeciality Hospital
state: Maharashtra
city: Pune
country: India
facility: Umarji Mother & Child Care Hospital
state: Maharashtra
city: Thane
country: India
facility: Swara Hospital
state: Maharashtra
city: Pune
country: India
facility: Silver Birch Multispecialty Hospital
state: Maharshtra
city: Varanasi
country: India
facility: Upendra Medicare Hospital
state: Uttar Pradesh
city: Varanasi
country: India
facility: Janta hospital & Maternity Centre
state: Uttar Pradesh
Study officials:
References: