None listed
Conditions
Interventions
Intervention1: E-OJ-01: 1 capsule (400 mg) orally to be taken after breakfast daily for 60 days
Control Intervention1: Placebo: Microcrystalline cellulose: 1 capsule (400 mg) orally to be taken after
Sponsors
Vedic Lifesciences Pvt Ltd
Eligibility
Inclusion 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
Exclusion criteria: 1 Individuals with a history of any pulmonary disorder. 2 Known cases of hypertension and diabetes mellitus. 3 SpO2 4 Random blood glucose (RBG) levels =140 mg/dl. 5 Hemoglobin (Hb) 6 Abnormal thyroid stimulating hormone (TSH) value ( 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: o Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine dependence. o 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Significant increase in the TTE as evaluated by Borg RPE scale while running on treadmill using Modified Bruce protocol from baseline to day 60 compared to the placebo.Timepoint: Day 0 and Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| Significant decrease in FAS total score for general fatigue from baseline to day 60 compared to placebo.Timepoint: Day 0, Day 15, Day 30 and Day 60;Significant decrease in HR at maximal fatigue as from baseline to day 60 compared to placebo.Timepoint: Day 0 and Day 60;Significant decrease in physical fatigue subscale score of FAS from baseline to day 60 compared to placebo.Timepoint: Day 0, Day 15, Day 30 and Day 60;Significant decrease in VAFS score for fatigue and increase in VAS for energy score from baseline to day 60 compared to placebo.Timepoint: Day 0 and Day 60;Significant increase in serum PGC-1a levels from baseline to day 60 compared to placebo.Timepoint: Day 0 and Day 60;Significant increase in VO2 max from baseline to day 60 compared to placebo.Timepoint: Day 0 and Day 60 | — |
Countries
India
Contacts
Public ContactDr Sonali Ghosh
Vedic Lifesciences Pvt Ltd
Outcome results
None listed