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

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

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.

Study Overview

• Status: Completed
• Conditions: Fatigue
• Intervention / Treatment: Other: E-OJ-01; Other: Microcrystalline cellulose

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Nerul, Maharashtra, India, 400706
      • D.Y. Patil deemed to be University,
    • Thane, Maharashtra, India, 421207
      • Shree Ashirwad Hospital
    • Thāne, Maharashtra, India, 400607
      • Dr. Preeti Bawaskar's Clinic
  • Rajasthan
    • Jaipur, Rajasthan, India, 302017
      • Jaipur National University Institute for Medical Science and Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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 exertion"The 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

Collaborators and Investigators

• Sponsor: Vedic Lifesciences Pvt. Ltd.
• Investigators: Study Director: Dr Shalini Srivastava, MD medicine, Vedic Lifesciences Pvt. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2022
• Primary Completion (Actual): September 4, 2023
• Study Completion (Actual): September 4, 2023

Study Registration Dates

• First Submitted: November 1, 2022
• First Submitted That Met QC Criteria: November 9, 2022
• First Posted (Actual): November 18, 2022

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: EB/220604/OXY/FATIGUE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No