To Study the Effect of Investigational Product on Fatigue and Cardiorespiratory Fitness in Healthy Adults.

Study Overview
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Brief Summary
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E-OJ-01 (Oxyjun®), a proprietary, standardized aqueous extract of TA, has been proven to improve cardiac output and thereby lead to better oxygenation capacity and exercise endurance. This, in turn, averts fatigue and improves physical functioning. Based on the previous studies of E-OJ-01 and the scientific literature available in support of the antioxidant and anti- inflammatory activity of TA bark, in the present study, it is hypothesized that E-OJ-01 will be able to reduce fatigue and improve the cardiorespiratory fitness of the male participants aged between 30 to 60 years.

Official Title
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A Randomized, Double-blind, Placebo-Controlled Study to Explore the Effect of E-OJ-01 on Fatigue and Cardiorespiratory Fitness in Healthy Adults.

Conditions
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Fatigue

Intervention / Treatment
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* Other: E-OJ-01
* Other: Microcrystalline cellulose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males aged ≥30 to ≤60 years. Body mass index (BMI) ≥18 and ≤29.9 kg/m2 VO2 max ≥20 ml/kg/ min but ≤35 ml /min/kg. FAS total score ≥22. Systolic blood pressure (SBP) ≤130 mm Hg and diastolic blood pressure (DBP) ≤89 mm Hg. Ready to abstain from alcohol, caffeine, and vigorous physical activity for 24 h before every study visit. Individuals who can comply and perform the procedures as per the protocol (consumption of study medications, biological sample collection procedures, and study visit schedule). Individuals who are literate enough to understand the purpose of the study and their rights. Individuals who can give written informed consent and are willing to participate in the study. Exclusion Criteria: Individuals with a history of any pulmonary disorder. Known cases of hypertension and diabetes mellitus. SpO2 < 96% Random blood glucose (RBG) levels ≥140 mg/dl. Hemoglobin (Hb) <13.0 g/dl. Abnormal thyroid stimulating hormone (TSH) value (<0.4μIU/ml or >4.2μIU/ml). Individuals with a history of COVID-19 in the last 3 months. Individuals currently on/or having a history of taking blood lipid-lowering medications. Individuals who are unable to run due to any joint disorder. History of smoking or active smokers using any form of tobacco. Individuals with substance abuse problems (within two years) defined as: Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine dependence. High-risk drinking as defined as consuming 5 or more alcohol-containing drinks on any day or 15 or more alcohol-containing drinks per week. Individuals who are currently on dietary supplements. Individuals who are currently on diuretics. History/symptoms of any cardiovascular disorder such as coronary artery disease or myocardial infarction. Individuals having clinically significant illnesses of the endocrine, immune, gastrointestinal, hepatobiliary, kidney, urinary, hematological, musculoskeletal system, and/or any inflammatory disorder. History of any significant neurological and psychiatric condition, which may affect the participation and inference of the studys endpoints. Participation in other clinical trials in the last 90 days before screening. Any condition that could, in the opinion of the Investigator, preclude the participants ability to successfully and safely complete the study or may confound study outcomes.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, Parallel Group, Placebo Controlled Trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E-OJ-01<br>1 capsule (400 mg) orally to be taken after breakfast daily for 60 days | Other: E-OJ-01<br>* 1 capsule (400 mg) orally to be taken after breakfast daily for 60 days<br>|
| Placebo Comparator: Microcrystalline cellulose<br>1 capsule (400 mg) orally to be taken after breakfast daily for 60 days | Other: Microcrystalline cellulose<br>* 1 capsule (400 mg) orally to be taken after breakfast daily for 60 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise capacity | To determine the effect of 60 days of product on exercise capacity as assessed by change in time-to-exhaustion (TTE) as evaluated by the Borg RPE scale while running on a treadmill using the Modified Bruce treadmill test protocol compared to the placebo. It is a 15-point single-item scale ranging from 6 to 20, with anchors ranging from 6 No exertion to 20 Maximum exertionThe Borg Score of ≥ 19 will indicate the point of volitional exhaustion, and the exercise protocol will be terminated at this point. | Day 0 baseline to Day 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiorepiratory fitness | The most accurate assessment of VO2 max is made by measuring expired air composition and respiratory volume during maximal exertion. VO2 max can be estimated from the peak exercise intensity during a maximal exercise test. The primary criterion for attaining VO2 max is a plateau in VO2. Several secondary criteria exist in the case of a plateau in VO2 not being reached, which include a rise in respiratory exchange ratio above 1.0 depending on the age, blood lactate concentration above 8 mmol/l, and an increase in heart rate to the age-predicted maximum. | Day 0 and Day 60 | 
| Exercise-induced fatigue and energy levels | The Visual Analog Scale for energy is anchored with the verbal cues low and high, while VAFS is anchored with the verbal cues no fatigue and very severe fatigue. A higher score indicates higher energy and fatigue on the respective scales | Day 0 and Day 60 | 
| General fatigue | The scale score is calculated by summing all items. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest. A total FAS score < 22 indicates no fatigue, and a score ≥ 22 indicates fatigue.The Minimal Clinically Important Difference (MCID) of at least 4 points or 10% change of the baseline value has been reported in cases of sarcoidosis. | Day 0, Day 15, Day 30 and Day 60 | 
| Physical fatigue | The scale score is calculated by summing all items. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest. A total FAS score < 22 indicates no fatigue, and a score ≥ 22 indicates fatigue.The Minimal Clinically Important Difference (MCID) of at least 4 points or 10% change of the baseline value has been reported in cases of sarcoidosis. | Day 0, Day 15, Day 30 and Day 60 | 
| Heart rate at maximal fatigue | Higher the percentile superior is the health | Day 0 and Day 60 | 
| Mitochondrial biogenesis | Energy balance as assessed by serum PGC-1α levels, a marker of mitochondrial biogenesis. | Day 0 and Day 60 |