A Randomized, Double Blind, Placebo Controlled Parallel Arm Clinical Study to Evaluate the Efficacy of LN18178 in Improving Muscle Strength, Aerobic Capacity and Body Composition in Healthy Young Males
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Change in Muscle strength (1-RM leg press)
研究概览
简要总结
The Purpose of the study is to evaluate the efficacy of LN18178 in improving muscle strength, aerobic capacity and body composition in healthy young males.
详细描述
A total of 120 male subjects aged between 36 and 50 years will be included in the study. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer-generated randomization list. The subjects will be assigned to either LN18178:400 mg or Placebo at 1:1 ratio. The subjects will be instructed to take one capsule daily in the morning after breakfast with water for 12 weeks. Apart from primary and secondary outcomes, the study will also record the vital signs and adverse events to evaluate the herbal composition safety and tolerability. The safety assessment of the LN18178 will also include routine laboratory investigations on blood, urine and clinical chemistry at screening and the final visit of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 36 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Untrained healthy male subjects aged between 36 and 50 years with a Body Mass Index (BMI) between 22 and 27 kg/m
- •Willingness to do exercise training program during the course of the study.
- •Subject considered generally healthy as per health history and routine clinical investigations.
- •Ability to understand the risks and benefits of the protocol.
- •Subject should provide written informed consent and agree to be available for regular follow up throughout the study duration.
- •Subjects who are sexually active must agree to use adequate non-hormonal contraception during the study
- •Subjects agree to maintain current diet and activity level.
- •Subject agrees not to start any new therapies for energy boosting supplements or protein supplements or health drinks during the course of the study.
- •Subjects willing to refrain from drinking coffee or caffeinated drinks or beverages during the study.
排除标准
- •Subjects who are resistance trained or undergoing resistance training.
- •Subjects with blood pressure more than or equal to 140/90 mmHg, fasting plasma glucose more than 125 mg/dL and abnormal ECG.
- •Subjects underwent treatment for COVID-19 within last 3 months or tested positive during the study will be excluded.
- •Evidence or history of musculoskeletal, respiratory, haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, malignancies.
- •Subjects diagnosed with sleep apnea or related disorders.
- •Subjects consuming medications that can interfere with muscle mass such as corticosteroids, testosterone replacement or anabolic drugs.
- •History of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
- •Subjects consuming alcohol (more than 3 standard drinks per week) or smokers ( more than 3 cigarettes per day).
- •Subjects who consume recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) or chewable tobacco products.
- •Subjects under medications including anti-hypertensives, antidepressants, anticholinergics, inhaled beta agonists, anti-hyperlipidemics, psychotropics etc.
- •Subjects using any centrally acting anorectic agents, drugs that inhibit the absorption of nutrients and endocannabinoid neuromodulators during the two weeks prior to enrolment into the study.
- •Subjects who underwent major surgical procedures in last 6 months.
- •Subject with HIV positive or history of any other STDs.
- •Subject has participated in a clinical study within the last 30 days prior to recruitment or concurrently participating in another study
研究组 & 干预措施
LN18178
400 mg, One capsule to be consumed in the morning after breakfast with water for 12 Weeks
干预措施: LN18178 (Dietary Supplement)
Placebo
One capsule to be consumed in the morning after breakfast with water for 12 Weeks
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in Muscle strength (1-RM leg press)
时间窗: Week 0, Week 2, Week 4, Week 8 and Week 12
It's the maximum amount of weight a subject can lift for one repetition of leg press. As the weight lifted increases, muscle strength also rises
次要结局
- Change in Lean body mass (DEXA)(Week 0 and Week 12)
- Change in Serum biomarkers (IGF-1 - Insulin-like growth factor-1)(Week 0 and Week 12)
- Change in Serum biomarkers Myostatin(Week 0 and Week 12)
- Change in subjective rating of Energy, Fatigue, Focus and Confidence using VAS(Week 0, Week 2, Week 4, Week 8 and Week 12)
- Change in Physical Activity Enjoyment Scale-8 (PACES)(Week 0, Week 2, Week 4, Week 8 and Week 12)
- Change in Muscle strength ( 1-RM bench press)(Week 0, Week 2, Week 4, Week 8 and Week 12)
- Change in Muscle endurance (Repetitions to failure for leg press and bench press using 80% 1RM)(Week 0, Week 2, Week 4, Week 8 and Week 12)
- Change in VO2 max testing (graded exercise test while O2 consumption measured)(Week 0 and Week 12)
- Change in Rate of Perceived Exertion (RPE) using 6-20 point Borg scale for exercise intensity(Week 0, Week 2, Week 4, Week 8 and Week 12)
- Change in subjective feeling of mental acuity, concentration, calmness and quality of sleep using VAS(Week 0, Week 2, Week 4, Week 8 and Week 12)
- Change in training volume/capacity(Week 0, Week 2, Week 4, Week 8 and Week 12)