CTRI/2024/06/068758尚未招募3 期
A Prospective, Single Arm, Open-label Clinical Study to Evaluate the Anabolic Efficacy of PRP-02 in Healthy Adults. - Nil
Amway Global Services India (AGSI)0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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.
研究者
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