Clinical trial NCT05621395: To Study the Effect of Investigational Product on Fatigue and Cardiorespiratory Fitness in Healthy Adults.
Official title: A Randomized, Double-blind, Placebo-Controlled Study to Explore the Effect of E-OJ-01 on Fatigue and Cardiorespiratory Fitness in Healthy Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2022-11-18
Enrollment: 74
Sex: MALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Parallel Group, Placebo Controlled Trial
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Healthy males aged ≥30 to ≤60 years.
2. Body mass index (BMI) ≥18 and ≤29.9 kg/m2
3. VO2 max ≥20 ml/kg/ min but ≤35 ml /min/kg.
4. FAS total score ≥22.
5. Systolic blood pressure (SBP) ≤130 mm Hg and diastolic blood pressure (DBP) ≤89 mm Hg.
6. Ready to abstain from alcohol, caffeine, and vigorous physical activity for 24 h before every study visit.
7. Individuals who can comply and perform the procedures as per the protocol (consumption of study medications, biological sample collection procedures, and study visit schedule).
8. Individuals who are literate enough to understand the purpose of the study and their rights.
9. Individuals who can give written informed consent and are willing to participate in the study.

Exclusion Criteria:

1. Individuals with a history of any pulmonary disorder.
2. Known cases of hypertension and diabetes mellitus.
3. SpO2 \< 96%
4. Random blood glucose (RBG) levels ≥140 mg/dl.
5. Hemoglobin (Hb) \<13.0 g/dl.
6. Abnormal thyroid stimulating hormone (TSH) value (\<0.4μIU/ml or \>4.2μIU/ml).
7. Individuals with a history of COVID-19 in the last 3 months.
8. Individuals currently on/or having a history of taking blood lipid-lowering medications.
9. Individuals who are unable to run due to any joint disorder.
10. History of smoking or active smokers using any form of tobacco.
11. 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.
12. Individuals who are currently on dietary supplements.
13. Individuals who are currently on diuretics.
14. History/symptoms of any cardiovascular disorder such as coronary artery disease or myocardial infarction.
15. Individuals having clinically significant illnesses of the endocrine, immune, gastrointestinal, hepatobiliary, kidney, urinary, hematological, musculoskeletal system, and/or any inflammatory disorder.
16. History of any significant neurological and psychiatric condition, which may affect the participation and inference of the studys endpoints.
17. Participation in other clinical trials in the last 90 days before screening.
18. 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.

Primary outcomes:
measure: Exercise capacity
timeFrame: Day 0 baseline to Day 60
Secondary outcomes:
measure: Cardiorepiratory fitness
timeFrame: Day 0 and Day 60
measure: Exercise-induced fatigue and energy levels
timeFrame: Day 0 and Day 60
measure: General fatigue
timeFrame: Day 0, Day 15, Day 30 and Day 60
measure: Physical fatigue
timeFrame: Day 0, Day 15, Day 30 and Day 60
measure: Heart rate at maximal fatigue
timeFrame: Day 0 and Day 60
measure: Mitochondrial biogenesis
timeFrame: Day 0 and Day 60
Other outcomes:
Locations:
city: Nerul
country: India
facility: D.Y. Patil deemed to be University,
state: Maharashtra
city: Thane
country: India
facility: Shree Ashirwad Hospital
state: Maharashtra
city: Thāne
country: India
facility: Dr. Preeti Bawaskar's Clinic
state: Maharashtra
city: Jaipur
country: India
facility: Jaipur National University Institute for Medical Science and Research Centre
state: Rajasthan
Study officials:
affiliation: Vedic Lifesciences Pvt. Ltd.
name: Dr Shalini Srivastava, MD medicine
role: STUDY_DIRECTOR
References: