Study on Isopower Womens Whey Protein - A Nutritional Supplement for Physically Active Wome
- Registration Number
- CTRI/2022/07/044218
- Lead Sponsor
- Essen Fooddies India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Stair Climbing Test : Increase of 10% from baseline <br/ ><br>2. 30 Second Chair Stand Test : Increase of 10% from baseline <br/ ><br>3. Borg Rating of Perceived Exertion : Decrease of 3 scores from baseline <br/ ><br>4. Hand Grip Strength using Dynamometer : Increase of 10% from baseline <br/ ><br>Timepoint: 1. Stair Climbing Test : Day 1, Day 45, Day 90 <br/ ><br>2. 30 Second Chair Stand Test : Day 1, Day 45, Day 90 <br/ ><br>3. Borg Rating of Perceived Exertion : Day 1, Day 45, Day 90 <br/ ><br>4. Hand Grip Strength using Dynamometer : Day 1, Day 45, Day 90 <br/ ><br>
- Secondary Outcome Measures
Name Time Method oneTimepoint: None