CTRI/2023/12/060650已完成Unknown
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 - Nil
Dr Deepti Khanna0 个研究点目标入组 24 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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
- •Participants fulfilling all inclusion criteria below will be considered for the study.
- •1. Healthy adult male or female participants aged greater than or equal to 25 and less than or equal to 60 years, will be considered.
- •2. 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.
- •3. Participant with normoglycemia which means fasting plasma glucose (FPG) less than 100mg/dl (as per ADA guidelines) will be considered.
- •4. Women in the reproductive age group if non-lactating and having negative test for pregnancy will be considered for the study,
- •5. Participant should not have taken part in a clinical trial in the last 3 months.
- •6. 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.
- •A. food allergy including lactose intolerance.
- •B. 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.
- •C. smoking or tobacco consumption.
- •D. diabetes and hyperglycaemia.
- •E. 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.
- •F. illness or has been hospitalized in the last 4 weeks preceding the start of the study.
- •G. 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.
研究者
相似试验
已完成
3 期
Clinical study of skin-beautifying effect of SkinCera supplementation.CTRI/2018/12/016661Vidya Herbs Pvt Ltd50
已完成
3 期
Clinical trial on eye health in healthy elderly volunteers.CTRI/2019/05/019392GENENCELL CO LTD
已完成
3 期
A study to evaluate effiacy and safety of KSM-66 Ashwagandha (Withania somnifera) on improving cardiorespiratory endurance in healthy athletic adultsCTRI/2012/05/002670SKP Labs Private Limited50
已完成
3 期
To Evaluate Efficacy and Safety of Nutricharge® S F on Weight Maintenance in Obese Subjects.CTRI/2014/09/004962Ms Trophic Wellness Pvt Ltd100
进行中（未招募）
不适用
A study to evaluate the efficacy of treatment with thyroid hormon in comparison to placebo in patients with borderline thyroid hypofunctioSubclinical hypothyroidismEUCTR2010-023509-37-DEInstitut für klinische Forschung und Entwicklung Berlin GmbH am St. Hedwig Krankenhaus