An Open Label, Prospective, Non-Randomised, Non-Comparative, SingleArm Clinical Study to Evaluate the Effectiveness, Safety and Tolerability of â??Isopower Womenâ??s Whey Proteinâ?? of Essen Fooddies India Pvt. Ltd as a Nutritional Supplement in Physically Active Adult Women

Essen Fooddies India Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年2月6日

试验速览

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•1.Clinically healthy physically active adult women, between the ages of 21 and 65 years (both ages inclusive).
•2.Subjects who are willing to abstain from use of herbal, allopathic or other nutritional supplements that are indicated at improving general health, Strength and Performance.
•3.Subjects who are not on rapid weight loss programs such as but not limited to keto, paleo, warrior, caveman diets. Intermittent fasting is permitted.
•4.Subjects who have scored 12-14 in Mini Nutritional Assessment MNA-SF Questionnaire at the time of screening.
•5.Subjects who are physically active i.e walk/cycle/perform other cardio activities for 30 minutes 3 times a week.
•6.Subjects who are willing to give informed consent for participation, able to comprehend and understand the responsibilities during screening and treatment period.
•7. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.

•1.Subjects with known hypersensitivity to the ingredients of the investigational product; is lactose intolerant or allergic to whey protein.
•2.Subjects who have an active infection, disease or disorder that will prevent them from fully satisfying the responsibilities of the study.
•3.Subjects with history of seizures, uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc.
•4.Subjects on remission from cancer of any type less than 5 years at the time of screening.
•5.Subjects who are planning a pregnancy and/or currently breastfeeding.
•6.Subjects who have participated in a clinical study less than 1 month before screening
•7.Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc.), any medical condition that is unstable/poorly controlled or other factor (e.g., planned relocation) that the Investigator felt would interfere with study evaluations and study participation.
•8.Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
•9.Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study.

发起方

Essen Fooddies India Pvt Ltd