CTRI/2024/11/077249已完成Unknown
A double blind Randomized clinical study to study the effect of Cosmix No Nonsense Plant Protein on Muscles gain and weight loss on subjects with Muscle Training
Cosmix Wellness Pvt Ltd1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年12月4日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Muscle Thickness
研究概览
简要总结
A single arm registered clinical study
Assessments
Muscle Measurement- Hamstring, Biceps, Chest with circumference measure
Bioelectrical impedance analysis BIA for Body fat, and resting metabolism
Subject’s Assessment Questionnaire for digestion, AE’s, Taste, Ease of Use, etc, as % users experienced X parameter.
Assessment timepoints: 4 weeks
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
入选标准
- •Gender: Male or Female 18 to 50 2) Subjects willing to give written informed consent 3) Women of child bearing potential must have a negative urine pregnancy test prior to study entry.
- •Are free of any systemic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events.
- •Are willing to join the training program throughout the study duration.
排除标准
- •Subjects who are pregnant, breast-feeding, or planning to become pregnant during the study.
- •Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, in the last 5 years, or any other confounding skin condition.
- •Have any condition that, in the opinion of the investigator, would confound the safety and/or efficacy assessments of the product.
- •Have participated in any interventional clinical trial in the previous 90 days.
- •Have a known sensitivity to any of the constituents of the test product including sensitivities to any ingredient
- •Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including corticosteroids.
结局指标
主要结局
Change in Muscle Thickness
时间窗: Day 0, Day 28
次要结局
- Change in Body Fat(Day 0, Day 28)
- Change in the weight(Day 0, Day 28)
- Change in the Resting Metabolism(Day 0, Day 28)
研究者
Dr Gaurav Gupta
CCFT Laboratories
研究点 (1)
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