A Randomised, Double-Blind, Placebo-controlled, study to determine the effect of Abelmoschus esculentus (Okra) extract on endurance in recreational runners.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 4
- 主要终点
- Mean change in the total distance covered on treadmill in the 15 min timed test.
研究概览
简要总结
Endurance is the ability to sustain prolonged physical or mental effort. It is a critical component of athletic performance, particularly in sports and activities that require sustained energy output over extended periods, such as long-distance running, cycling, and swimming. This study focuses on the effect of okra extract on endurance in recreational runners. Recreational endurance runners are individuals who engage in long-distance running as a form of exercise, hobby, or competitive sport, but not at a professional or elite level. In preclinical studies okra had demonstrated anti-fatigue activity. Despite the abundance of anecdotal evidence and preclinical studies suggesting these benefits, no clinical trials have yet been conducted to confirm these effects in human subjects. By investigating okra’s impact on endurance and recovery, this trial aims to provide scientifically rigorous data that could validate its use as a natural ergogenic aid. The findings may offer a novel nutritional strategy to improve performance and well-being among recreational endurance runners.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Males and Females 25 to 40 years of age (1:1 ratio) Body Mass Index between from 18.5 to 24.9 kg/m2 Being recreationally active – Habitual running for 30 min for at least 3 days in a week for the past 3 months.
- •IPAQ vigorous activity not less than 720 MET minutes per week.
- •Normotensive (seated, resting systolic blood pressure less than 140 mm Hg and diastolic blood pressure less than 90 mm Hg. Normal seated, resting heart rate (less than 90 beats per minute).
- •Subjects who are willing to refrain from using protein, vitamin, mineral and herbal supplements for the study period.
- •Ability to follow all instructions in the study protocol and be willing to give written informed consent.
排除标准
- •COVID positive in the past 6 months.
- •Received any vaccinations in the past 6 months.
- •Current use of prescription or over-the-counter medications or unwillingness or inability to discontinue use of these medications at least 4 weeks before beginning the study.
- •Cardiovascular complications.
- •Use of protein, vitamin, mineral, and herbal supplements 1 week before the study.
- •Alcoholic (greater than 2 pegs(60ml)per day) and smoking (has not stopped within 3 months of the study) Medical problems that would be a direct physical limitation.
- •Current treatment for depression, alcohol or substance abuse, or psychosis Women of childbearing age intending for pregnancy or are pregnant, breastfeeding, or willing to practice contraception.
- •Any condition, including laboratory abnormalities, that in the opinion of investigator places the volunteer at an unacceptable risk or deems the volunteer not suitable for participation in the study.
- •Subjects who are unwilling to abstain from consuming okra and any other dietary supplements and to maintain their normal training and dietary habits.
- •Subjects who participated in a clinical trial for the past 3 months.
- •Unwilling to provide written informed consent.
结局指标
主要结局
Mean change in the total distance covered on treadmill in the 15 min timed test.
时间窗: Day4 and Day34
次要结局
- Mean change in peak power output in the vertical jump test(Day4 & Day34.)
- Mean change in time to exhaustion in the Barbell lift & hold test(Day4 & Day34.)
- Mean change in Borg 6-20 RPE scale(Day4 & Day34)
- Mean change in the mean score of FSS, & VAS-F(Day4 & Day34)
- Mean change in biomarkers(from D4 to D34)
研究者
Dr Binu T Kuruvilla
Arjuna Natural Pvt Ltd