CTRI/2024/06/068758尚未招募Phase 3 4
A Prospective, Single Arm, Open-label Clinical Study to Evaluate the Anabolic Efficacy of PRP-02 in Healthy Adults.
Amway Global Services India (AGSI)1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年6月21日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in muscle strength including handgrip strength, Pectoral strength and Quadriceps strength
研究概览
简要总结
This is a clinical study to evaluate the efficacy of PRP-02. Subjects meeting all inclusion and exclusion criteria will be enrolled in the study after signing a written informed consent. The study will be conducted in 6 visits (4 onsite visits and 2 telephonic follow-ups) over 28 days. The efficacy assessments include changes in muscle strength, body composition, and skin fold thickness. Blood, urine, and fecal samples will be collected for safety and efficacy assessments. The overall safety and adverse events will be monitored throughout the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy vegetarian, adult male and female subjects, aged 18 to 45 years (both inclusive) 2.Subjects who are not taking any supplements with anabolic agents (muscle building) and/or protein powder in the past 4 weeks.
- •3.Subjects who have a habitual protein intake of less than or equal to 0.8 g/kg/day based on a food frequency questionnaire 4.Subjects with Body mass index (BMI) between 19-24.9 (kg/m2) with a stable weight over the past 3 months 5.Females of childbearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test at screening 6.Subjects willing to adhere with their routine diet, physical activity, and general lifestyle throughout the study.
- •7.Subjects who are able to understand the benefits and risks of the study protocol, follow the protocol and come for follow-up visits.
- •8.Must be willing and able to give informed consent and comply with the study procedures.
排除标准
- •1.Subjects diagnosed with Type 1 and 2 diabetes mellitus 2.Subjects currently on medication/ HRT (Hormone Replacement Therapy) 3.Subjects with musculoskeletal disorders that make it difficult to exercise 4.Women in the reproductive age group not willing to use standard contraceptive measures. 5.Subjects with history of oEndocrine hypothalamic- pituitary disease, women with PCOS, adrenal disorder, hypothyroidism oChronic kidney disease, oRenal stones, oLiver dysfunction (with elevated enzyme levels), oEating disorders, oChronic gastrointestinal disorders oInflammatory bowel disease (IBD) or celiac disease, oMetabolic disorders like hypertension, cardiovascular diseases.
- •that might impair the outcomes oMalignancy which is currently active or in remission for less than five years after last treatment 6.Subjects with unstable weight (± 5 % fluctuation in their body weight for past 3 months at study entry) 7.Subjects who have undergone a surgical procedure within 1 month of signing informed consent and currently participating or has participated in a study with an investigational drug or device 8.Subjects who maybe allergic to soy or wheat or pea. 9.Known HIV or Hepatitis B positive or any other immuno-compromised state 10.Pregnant and lactating women 11.Currently participating or having participated in another clinical trial during the last 30 days prior to screening or are likely to simultaneously participate in another clinical study. 12.Subjects who are doubtful to comply with study procedures for mental, psychological or social reasons. 13.Subjects who are not willing to sign the informed consent and follow the study protocol. 14.Any additional condition(s) that in the Investigators opinion that may interfere with subject treatment, assessment or compliance with the protocol and would warrant exclusion from the study or prevent the subject from completing the study.
结局指标
主要结局
Change in muscle strength including handgrip strength, Pectoral strength and Quadriceps strength
时间窗: Baseline, Day 14, Day 28
次要结局
- Biomarkers and Overall Safety(Baseline, Day 14, Day 28)
研究者
Dr Harshith C S
BGS Global Institute of Medical Sciences
研究点 (1)
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