| CTRI Number |
CTRI/2022/07/044218 [Registered on: 21/07/2022] Trial Registered Prospectively |
| Last Modified On: |
21/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on Isopower Womens Whey Protein - A Nutritional Supplement for Physically Active Women |
|
Scientific Title of Study
|
An Open Label, Prospective, Non-Randomised, Non-Comparative, Single
Arm 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 Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AHC/NUT/066/20 Version 01 03May22 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr VT Sriraam |
| Designation |
Investigator |
| Affiliation |
Aurous HealthCare R&D India Pvt. Ltd. |
| Address |
#180/109, G1&G2, RR Villa,
Rangarajapuram Main Road, Kodambakkam,
Chennai
TAMIL NADU
600024
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VT Sriraam |
| Designation |
Investigator |
| Affiliation |
Aurous HealthCare R&D India Pvt. Ltd. |
| Address |
#180/109, G1&G2, RR Villa,
Rangarajapuram Main Road, Kodambakkam,
TAMIL NADU
600024
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr VT Sriraam |
| Designation |
Investigator |
| Affiliation |
Aurous HealthCare R&D India Pvt. Ltd. |
| Address |
#180/109, G1&G2, RR Villa,
Rangarajapuram Main Road, Kodambakkam,
TAMIL NADU
600024
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
|
Source of Monetary or Material Support
|
| Essen Fooddies India Pvt. Ltd. |
|
|
Primary Sponsor
|
| Name |
Essen Fooddies India Pvt Ltd |
| Address |
KINFRA Park, Kakkancherry
Malappuram 673635,
Kerala, India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Aurous HealthCare Research and Development India Private Limited |
#180/109, G1&G2, RR Villa,
Rangarajapuram Main Road, Kodambakkam,
Chennai 600024 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr VT Sriraam |
Raam Clinic |
Department of General/Family Medicine
Room no 7. #180/109, G1&G2, RR Villa,
Rangarajapuram Main Road, Kodambakkam,
Chennai
TAMIL NADU |
9840909155
md@auroushealthcare.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Universal Ethics Committee (A Unit of Aurous HealtCare Research and Development India Pvt. Ltd ) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Clinically Healthy Physically Active Adult Women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Isopower Womens Whey Protein |
Route of Administration : Oral
Formulation : Powdered Nutritional Formulation
Dose : 33g in 150ml cold water
Dosage : OD for 3 months
|
| Comparator Agent |
None |
None |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Stair Climbing Test : Increase of 10% from baseline
2. 30 Second Chair Stand Test : Increase of 10% from baseline
3. Borg Rating of Perceived Exertion : Decrease of 3 scores from baseline
4. Hand Grip Strength using Dynamometer : Increase of 10% from baseline
|
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 Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "37"
Final Enrollment numbers achieved (India)="37" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
25/07/2022 |
| Date of Study Completion (India) |
20/01/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None. Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 Whey
Protein
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 ages
of 21 and 65 years (both ages inclusive).
Treatment Arms : One. Non Comparative Single Arm
Study
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
Background
of the Study : A nutritional state resulting from an inadequate intake of
nutrients, particularly in energy (though also protein and micronutrients),
leads to reduced mass, reduced requirement, reduced work, physiologic and
metabolic changes, changes in the body composition and loss of tissue reserve. Women’s
widespread ignorance about matters related to their health poses a serious
obstacle to their well-being. Women in good health can fulfill their multiple
roles such as generating income, ensuring their families nutrition, having
healthy children and also for the socioeconomic development of the country.
Dietary supplements would seem to be the obvious way to plug gaps in their
diet.
Purpose of the Study : Isopower Women’s Whey Protein
by Essen Fooddies Pvt. Ltd has
been formulated with required amount of nutrients (Proteins, Vitamins &
Minerals) for women health and fitness. This clinical study is designed
as an Open Label, Prospective, Non-Randomised, Non Comparative, Single Arm
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 in physically
active adult women.
|