CTRI/2023/11/060027已完成4 期
A Randomized, Placebo-controlled, Blinded Study to Evaluate Efficacy of EB-PA as Protein Amplifier for Skeletal Muscle Strength & Growth
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 3
- 主要终点
- To assess improvement in muscle strength after administration of Investigational Product (IP) as assessed by increase in Upper & lower body 1RM (Repetition Maximum) weight
研究概览
简要总结
The present study is a randomized, placebo-controlled, double blinded study to evaluate efficacy of EB-PA as protein amplifier for skeletal muscle strength & growth in males with active lifestyle. Approximately 160 subjects aged between ≥ 20 and ≤ 35 years will be screened and 138 participants are to be randomized. Both the IP and placebo study arms will have at least 40 completed subjects after accounting for the screening failure and dropout/withdrawal rate of 14% and 13 % respectively (Total 120 completers). The treatment duration for all the study subjects will be 30 days. The sustained effect of the product will be observed for next 7 days, wherein, the subjects will be abstaining from the protein and IP supplementation and will exercise at their ease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Male
入选标准
- •Males aged 20 to 35 years with active lifestyle with moderate physical activity level as per International Physical Activity Questionnaire
- •Recreationally gym goer with history of at least 1 month of endurance training (Example.
- •functional exercises)
- •Not participating in resistance type training (Example external or body weight training) for less than equal to 3 months prior to screening
- •Body mass index (BMI) 22 to 29.9 kg/m
- •Individuals with a 1-RM strength defined by Upper Body more than equal to 25 Kgs and Lower Body more than Equal to 100 Kgs will be included in the study
- •Ready to refrain from caffeinated products and intense strength/ endurance exercise for 24 hrs prior to the exercise lab visit
- •Fasting Blood Glucose Less than Equal to 110 mg/ dl.
- •Systolic Blood Pressure less than equal to 129 mmHg and Diastolic Blood Pressure Less than equal to 89 mmHg
- •TSH (thyroid stimulating hormone) more than equal to 0.4 and Less than Equal to 4.9 mIU/L.
排除标准
- •Engaged in structured weight training for more than 3 months prior to screening.
- •Presence of chronic disease.
- •Changes in body weight more than 4.5 kg (10 pounds) in the past three months as assessed by history.
- •Subjects diagnosed with hypertension.
- •Subjects who are diagnosed with Type I and Type II Diabetes Mellitus.
- •History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic or neurologic disorders.
- •Allergy to whey protein or herbal ingredients.
- •Subjects who have any other disease or condition, or are using any medication, that in the judgement of the investigator would put them at unacceptable risk for participation in the study or may interfere with evaluations in the study or noncompliance with treatment or visits.
- •Subjects who have been part of a clinical study within 90 days prior to the screening.
- •Subjects who have used whey or other supplemental proteins anytime in the last 3 months.
结局指标
主要结局
To assess improvement in muscle strength after administration of Investigational Product (IP) as assessed by increase in Upper & lower body 1RM (Repetition Maximum) weight
时间窗: Day 0 to Day 30
次要结局
- To assess the effect of IP on increase in muscle endurance as assessed by increase in exercise volume calculated as load multiplied by number of repetition (upper and lower body exercise) completed at more than equal to 70 percent of Screening 1 RM.(Day 0 to Day 30)
- To assess the effect of OP on Increase in muscle (hamstring) flexibility as assessed by increase in distance for V sit and reach test.(Day 0 to Day 30.)
- To assess the effect of IP on improvement in muscle mass as indicated by increase in fat free mass (FFM), lean muscle mass and android fat by DXA.(Day 0 to Day 30)
- To assess the effect of IP on improvement in grip strength as indicated by increase in non-dominant hand grip strength.(Day 0 to Day 30)
- To assess the effect of IP on improvement in metabolic health as indicated by waist to height ratio.(Day 0 to Day 30)
研究者
Dr Shalini Srivastava
Vedic Lifesciences Pvt. Ltd.
研究点 (3)
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