A Randomized, Placebo-controlled, Blinded, Pilot Study to Evaluate Efficacy of Botanical Extracts as Protein Amplifier for Skeletal Muscle Strength & Growth.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- 1-Repetition Maximum
研究概览
简要总结
Sponsor proposes ingredients that when added to daily whey supplementation, can lead to increased muscle strength, improves sleep quality and reduction in fatigue level.
详细描述
The present study is a randomized, blinded, placebo-controlled, pilot study. Approximately 40 males aged between ≥ 20 and ≤ 35 years, will be screened. Each trial arm will have at least 5 completed after accounting for dropout/withdrawal rate of 20%. The treatment duration for all the study participants will be 28 to 56 days (Day 56 is only applicable for participants with less than 10% increase in weight leg pressed for 1 RM on Day 28. All participants in arm 1 of study will have their end of study visit on Day 28).Sponsor proposes ingredients that when added to daily whey supplementation, can lead to increased muscle strength, improves sleep quality and reduction in fatigue level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males aged 20 - 35 years with active lifestyle moderate physical activity level as per International Physical Activity Questionnaire.
- •Recreationally active but not participating in resistance type training on regular basis.
- •Body mass index (BMI) 22 - 29.9 kg/ m2
- •Participants with an Insomnia Severity Index score ≥7 and ≤14
- •Ready to refrain from caffeinated products and intense strength/ endurance exercise for 24 hrs. prior to the exercise lab visit.
- •Fasting Glucose ≤ 110 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 during the previous 12 months prior to screening.
- •Presence of chronic disease.
- •Changes in body weight more than 4.5 kg (10 pounds) in the past three months.
- •Participants with uncontrolled hypertension.
- •Participants who are diagnosed with Type II Diabetes Mellitus.
- •History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic, or neurologic disorders.
- •Allergy to whey or herbal ingredients.
- •Participants who have any other disease or condition, or are using any medication, that in the judgment 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.
- •Participants who have been part of a clinical trial within 90 days prior to the screening.
- •Participants who have used whey or other supplemental proteins anytime in last 3 months
结局指标
主要结局
1-Repetition Maximum
时间窗: Day 0 to Day 28 and /or day56
The final weight lifted successfully for atleast 1 repetition but could not complete 3 repetition will be recorded as 1- RM. Change in muscle strength as indicated by increase in 1Repetition Maximum leg press weight
次要结局
- Visual Analogue Scale for Fatigue(Day 0 to Day 28 and /or day56)
- Body fat composition: Lean Muscle Mass by Dual-energy X-ray absorptiometry(Day 0 to Day 28 and /or day56)
- Mid-thigh Girth(Day 0 to Day 28 and /or day56)
- Digestive diary(Day 0 to Day 28 and /or day56)
- Quality of Sleep: Modified Insomnia Severity Index(Day 0 to Day 28 and /or day56)