A Randomized, Double-blind, Placebo-controlled, Parallel group, Three-arm Study to Evaluate the Efficacy and Safety of Ashwagandha Root Extract Capsules on Improving Exercise Performance and Cardiorespiratory Endurance in Conjunction with Exercise Training in Healthy Adult Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Muscle endurance (measured by leg extension and bench press through 1 RM)
研究概览
简要总结
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Three-Arm Study to Evaluate the Efficacy and Safety of Ashwagandha Root Extract Capsules on Improving Exercise Performance and Cardiorespiratory Endurance in Conjunction with Exercise Training in Healthy Adult Subjects.
Study Type: Interventional
Objective:
Primary Objective:
To evaluate the superiority of Ashwagandha root extract capsules in improving muscle strength & endurance and cardiorespiratory endurance in healthy adult male subjects undergoing exercise training in comparison to placebo.
Secondary Objectives:
To compare the efficacy of Ashwagandha root extract capsule low dose vs. Ashwagandha root extract capsule high dose in improving muscle strength & endurance and cardiorespiratory endurance in healthy adult male subjects undergoing exercise training.
To assess the safety and tolerability of the study supplements.
To assess the effect on lean body mass of Ashwagandha root extract capsules in comparison with placebo.
To evaluate the changes in hormonal profiles in Ashwagandha root extract capsules supplemented subjects in comparison with placebo.
To evaluate recovery from exercise-induced muscle damage in Ashwagandha root extract capsules supplemented subjects, in comparison with placebo.
Design: A randomized, double-blind, placebo-controlled, parallel group, three-arm study.
Efficacy Endpoints:
Primary Endpoints:
Change from the baseline to the end of the study in:
Muscle strength (measured by leg extension and bench press through one repetition maximum (1 RM))
Muscle endurance (measured by leg extension and bench press through 1 RM)
Cardiorespiratory endurance exercise by treadmill (maximal oxygen uptake (VO2 max))
Secondary Endpoints:
Change from the baseline to the end of the study in:
Body composition by dual-energy X-ray absorptiometry (DEXA) scan (to evaluate the increase in lean muscle mass/ reduction in fat component)
Serum testosterone level (free and total)
Serum cortisol level
Muscle damage markers in serum (creatine phosphokinase (CK) and lactate dehydrogenase (LDH) level) Safety Endpoints: ï‚· Adverse events (AEs), frequency and severity
Number of subjects who discontinue study due to adverse events
Number of subjects: A total of 120 healthy adult male subjects (i.e. Arm 1: 40, Arm 2: 40, Arm 3: 40) need to be enrolled in the study to achieve 80% power considering 15% dropout rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Healthy adult male subjects aged between 21-45 years with a BMI between 22 and 29 kg/m
- •Subjects willing to be acquainted with the gym equipment for 1-2 weeks before enrolling in the study.
- •Ability to understand the risks/benefits of the protocol.
- •Subjects considered generally healthy as per health history and routine clinical investigations.
- •Subjects agree to perform physical activities as stated in the protocol in the presence of physical trainer.
- •Subjects should provide written informed consent and agree to be available for regular followup throughout the study duration.
- •Subjects agree not to start any new therapies or energy boosting supplements or protein supplements or health drinks during the study.
- •Agree to follow the dietary instructions as advised by the nutritionist during the counselling session.
排除标准
- •Subjects who are consuming medications that can interfere with muscle mass such as corticosteroids, testosterone replacement or anabolic drugs.
- •Concomitant administration or history of consumption within seven (7) days prior to the screening of herbal/nutraceutical/ vitamin-minerals supplements.
- •Concomitant use of any supplement including protein/amino acids/creatine/any other product used for muscle growth/recovery/ stamina and cardiorespiratory endurance.
- •Subjects using any other therapies that would affect body composition other than those revealed during the recruitment process.
- •History or presence of any cardiovascular or bronchial / airway disease including but not limited to hypertension, myocardial infarction, coronary artery disease, cardiac failure, angina, arrhythmia, bronchial asthma.
- •Clinically significant 12- Lead ECG.
- •History or presence of any chronic systemic disorder including but not limited to endocrine, neurological, hepatic or renal disease, diabetes mellitus, stroke.
- •Subjects having clinically significant abnormal findings as per investigator’s discretion in the hematological and biochemical laboratory tests.
- •Human immunodeficiency virus (HIV) positive subjects.
- •Subjects who consume alcohol or smoke.
- •Subjects having a history or presence of psychiatric disorder.
- •Subjects with a history of any major surgical procedure within the last 6 months.
- •The subjects who have participated in a clinical study within the last 90 days before recruitment.
- •Institutionalized subjects.
结局指标
主要结局
Muscle endurance (measured by leg extension and bench press through 1 RM)
时间窗: Change from the baseline to the end of the study
Cardiorespiratory endurance exercise by treadmill (maximal oxygen uptake (VO2 max))
时间窗: Change from the baseline to the end of the study
Muscle strength (measured by leg extension and bench press through one repetition maximum (1 RM))
时间窗: Change from the baseline to the end of the study
次要结局
- Body composition by dual-energy X-ray absorptiometry (DEXA) scan (to evaluate the increase in lean muscle mass/ reduction in fat component)(Serum testosterone level (free and total))