An Open Label, Prospective, Non-Randomised, Non-Comparative, SingleArm Clinical Study to Evaluate the Effectiveness, Safety and Tolerability of “Isopower Women’s Whey Protein†of Essen Fooddies India Pvt. Ltd as a Nutritional Supplement in Physically Active Adult Women
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- 2. 30 Second Chair Stand Test : Increase of 10% from baseline
Study Overview
Brief Summary
Study Design : Open Label, Prospective, Non-Randomised,Non-Comparative, Single Arm Clinical Study
Indication : Nutritional Supplement for Clinically Healthy Physically Active Adults
Investigational Product Details Name : Isopower Women’s WheyProtein Route of Administration : Oral Dose : 33g in 150ml cold water Dosage : OD for 3 months
Subject Population : Clinically healthy physically active adult women between the agesof 21 and 65 years (both ages inclusive).
Treatment Arms : One. Non Comparative Single ArmStudy
Number of Subjects : 35 Subjects
Efficacy Assessments: 1. Stair Climbing Test : Day 1, Day 45, Day 90 2. 30 Second Chair Stand Test : Day 1,Day 45, Day 90 3. Borg Rating of Perceived Exertion : Day 1, Day 45, Day 90 4. Hand Grip Strength using Dynamometer : Day 1, Day 45, Day 90
Safety Assessments: 1. Clinical Safety : CBC, Serum Biochemistry 2. Monitoring of Adverse Events
Backgroundof the Study : A nutritional state resulting from an inadequate intake ofnutrients, particularly in energy (though also protein and micronutrients),leads to reduced mass, reduced requirement, reduced work, physiologic andmetabolic changes, changes in the body composition and loss of tissue reserve. Women’swidespread ignorance about matters related to their health poses a seriousobstacle to their well-being. Women in good health can fulfill their multipleroles such as generating income, ensuring their families nutrition, havinghealthy children and also for the socioeconomic development of the country.Dietary supplements would seem to be the obvious way to plug gaps in theirdiet.
Purpose of the Study : Isopower Women’s Whey Proteinby Essen Fooddies Pvt. Ltd hasbeen formulated with required amount of nutrients (Proteins, Vitamins &Minerals) for women health and fitness. This clinical study is designedas an Open Label, Prospective, Non-Randomised, Non Comparative, Single ArmClinical Study to Evaluate the Effectiveness, Safety and Tolerability of“Isopower Women’s Whey Protein†of Essen Fooddies India Pvt. Ltd as a NutritionalSupplement in in physicallyactive adult women.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 21.00 Year(s) to 65.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •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.
- •Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
Exclusion Criteria
- •1.Subjects with known hypersensitivity to the ingredients of the investigational product; is lactose intolerant or allergic to whey protein.
- •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.
Outcomes
Primary Outcomes
2. 30 Second Chair Stand Test : Increase of 10% from baseline
Time Frame: 1. Stair Climbing Test : Day 1, Day 45, Day 90 | 2. 30 Second Chair Stand Test : Day 1, Day 45, Day 90 | 3. Borg Rating of Perceived Exertion : Day 1, Day 45, Day 90 | 4. Hand Grip Strength using Dynamometer : Day 1, Day 45, Day 90
1. Stair Climbing Test : Increase of 10% from baseline
Time Frame: 1. Stair Climbing Test : Day 1, Day 45, Day 90 | 2. 30 Second Chair Stand Test : Day 1, Day 45, Day 90 | 3. Borg Rating of Perceived Exertion : Day 1, Day 45, Day 90 | 4. Hand Grip Strength using Dynamometer : Day 1, Day 45, Day 90
3. Borg Rating of Perceived Exertion : Decrease of 3 scores from baseline
Time Frame: 1. Stair Climbing Test : Day 1, Day 45, Day 90 | 2. 30 Second Chair Stand Test : Day 1, Day 45, Day 90 | 3. Borg Rating of Perceived Exertion : Day 1, Day 45, Day 90 | 4. Hand Grip Strength using Dynamometer : Day 1, Day 45, Day 90
4. Hand Grip Strength using Dynamometer : Increase of 10% from baseline
Time Frame: 1. Stair Climbing Test : Day 1, Day 45, Day 90 | 2. 30 Second Chair Stand Test : Day 1, Day 45, Day 90 | 3. Borg Rating of Perceived Exertion : Day 1, Day 45, Day 90 | 4. Hand Grip Strength using Dynamometer : Day 1, Day 45, Day 90
Secondary Outcomes
No secondary outcomes reported