NCT05926609招募中不适用
A Placebo-Controlled, Single-Blind Sequential Study to Evaluate the Efficacy of EB-PA on Muscle Mass and Strength in Occasional Gym Goer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) from baseline on
研究概览
简要总结
The present study is a placebo- controlled, single-blind sequential study. Total of 40 males aged between ≥ 18 years and ≤35 years will be screened. Assuming screen failure and dropout rate in this study, a minimum of 30 participants should complete the study. The treatment duration for all the study participants will be 60 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males aged ≥18 to ≤ 35 years with moderate physical activity levels as per International Physical Activity Questionnaire (IPAQ-SF).
- •Occasionally gym goer with a history of at least 1 month of training but not participating in the resistance-type activity for ≥3 months.
- •Habitual non-veg eater
- •Body mass index (BMI) 22 - 29.9 kg/ m2
- •Waist Circumference 94-102 cm
- •Ready to refrain from caffeinated products and intense strength/ endurance exercise for 24 hrs before the exercise lab visit.
- •Fasting blood Glucose ≤ 125 mg/ dl
- •Systolic Blood Pressure ≤ 129 mm Hg and Diastolic Blood Pressure ≤ 89 mm Hg
- •TSH (thyroid stimulating hormone) ≥0.4 and ≤ 4.9 mIU/L
排除标准
- •Engaged in structured weight training for more than 12 months before screening.
- •Presence of chronic disease
- •Changes in body weight of more than 4.5 kg (10 pounds) in the past three months
- •Individuals with uncontrolled hypertension
- •Known cases of Type II Diabetes mellitus
- •History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic, or neurologic disorders
- •Individuals who have any other disease or condition or are using any medication that, in the investigator's judgment would put them at unacceptable risk for participation in the study or may interfere with evaluations or non-compliance with treatment or visits
- •Individuals who have been part of a clinical trial within 90 days before the screening
- •Individuals who have used whey or other supplements anytime in the last 3 months
结局指标
主要结局
To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) from baseline on
时间窗: Day 61
Improvement in muscle strength as assessed by isokinetic peak torque (measured during knee extension and flexion)
次要结局
- To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on(Day 0, Day 31 and Day 61)
研究者
研究点 (4)
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