CTRI/2023/12/060650已完成不适用
A Prospective, Single Blind, Randomized, Placebo Controlled, Crossover, Study to Determine the efficacy of two Protein Supplements on the Essential Amino Acid (EAA) Levels in healthy, adults
Dr Deepti Khanna1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年12月29日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To assess the efficacy of Protein Supplements on the Essential Amino Acid (EAA) Levels in healthy adults
研究概览
简要总结
The present study aims to study the effect of protein supplement in milk on plasma levels of amino acid profile in healthy adults greater than or equal to 25 to less than or equal to. 60 years of age. The main objective of this study is to investigate the effect of protein-based, oral nutritional supplement (P-ONS) given in milk on the plasma levels of essential amino acids (EAAs) in healthy Indian adults, using targeted essential amino acid (EAA) analysis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants fulfilling all inclusion criteria below will be considered for the study.
- •Healthy adult male or female participants aged greater than or equal to 25 and less than or equal to 60 years, will be considered.
- •Participants having a Body Mass Index (BMI) in the range 20.0 to 30.0 kg/m2 (both inclusive) and weight of at least 50 kg will be considered.
- •Women in the reproductive age group if non-lactating and having negative test for pregnancy will be considered for the study,
- •Participant should not have taken part in a clinical trial in the last 3 months.
- •Participant should be able to read and understand and ready to provide written informed consent.
排除标准
- •1.Participants having resting hypotension i.e., BP less than 90 and 60 or hypertension BP more than 139 and 89 will be excluded.
- •2.Participants having pulse rate below 50 per min.
- •and above 99 per min will be excluded.
- •3.Participants with known medical history of any of the conditions listed below, will be excluded.
- •food allergy including lactose intolerance.
- •drug abuse or alcoholism i.e., alcohol consumption more than 2 units per day or 10 units per week one unit of alcohol 50 ml spirit or 200 ml wine or 500ml beer.
- •smoking or tobacco consumption.
- •diabetes and hyperglycaemia.
- •intake or administered protein supplements or any drugs or over the counter or prescribed medications including any enzyme modifying drugs in the last 14 days prior to the study.
- •illness or has been hospitalized in the last 4 weeks preceding the start of the study.
- •gastrointestinal, liver or kidney disease, or presence active peptic ulceration or a history of peptic ulceration or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
- •4.Potential participants who are related e.g., husband and wife or brother and sister or persons living in the same household e.g., tenants sharing a household cannot be recruited together in the study one of participants will be excluded.
- •5.Participants following any protein-rich dietary regime, muscle toning or body building program and not willing to discontinue such regime or program during the conduct of study will be excluded.
- •6.Any potential participant who is an employee of Sponsor, or the site CRO conducting the study will be excluded.
- •The participants must also not be related to any personnel conducting the study.
结局指标
主要结局
To assess the efficacy of Protein Supplements on the Essential Amino Acid (EAA) Levels in healthy adults
时间窗: There are a total of three visits scheduled on Day 1, Day 9, and Day 17. During each visit, samples will be collected at predose and at 15, 30, 60, and 90 minutes after the administration of the product.
次要结局
- Difference in the level of each TSAA, post supplementation between the arms will be considered for significance i.e., change between the arms Arm1 with Placebo & Arm 2 with Placebo.(There are a total of three visits scheduled on Day 1, Day 9, and Day 17. During each visit, samples will be collected at predose and at 15, 30, 60, and 90 minutes after the administration of the product.)
研究者
Dr Sanjay Mishra
Auriga Research Private Limited
研究点 (1)
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