A Randomized, Double-blind, Placebo-Controlled Study to Explore the Effect of E-OJ-01 on Fatigue and Cardiorespiratory Fitness in Healthy Adults.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 8
- 主要终点
- Exercise capacity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
盲法说明
Sequentially numbered, sealed, opaque envelopes
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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 ≥
- •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.
排除标准
- •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.
结局指标
主要结局
Exercise capacity
时间窗: Day 0 baseline to Day 60
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.
次要结局
- Mitochondrial biogenesis(Day 0 and Day 60)
- Cardiorepiratory fitness(Day 0 and Day 60)
- General fatigue(Day 0, Day 15, Day 30 and Day 60)
- Exercise-induced fatigue and energy levels(Day 0 and Day 60)
- Physical fatigue(Day 0, Day 15, Day 30 and Day 60)
- Heart rate at maximal fatigue(Day 0 and Day 60)