| CTRI Number |
CTRI/2022/07/043981 [Registered on: 13/07/2022] Trial Registered Prospectively |
| Last Modified On: |
21/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study on "Essen Plant Protein" - A nutritional powdered supplement for active adults (exercisers, gym goers) for protein supplementation. The Protein is vegan - plant based protein only. |
|
Scientific Title of Study
|
An Open Label, Prospective, Randomised, Non-Comparative, Two Arm Clinical Study to Evaluate the Effectiveness, Safety and Tolerability of “Essen Plant Protein†of Essen Fooddies India Pvt. Ltd as a Nutritional Supplement in Physically Active Adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AHC/NUT/078/22 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
600034
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
600034
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
600034
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 600034 |
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Clinically Healthy Physically Active Adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Essen Plant Protein : Chocolate Flavour |
Route of Administration : Oral
Formulation : Plant Based Powered Nutritional Formulation
Dose : 35g (6 levelled scoops) in 500ml of water
Dosage : OD for 3 months
|
| Intervention |
Essen Plant Protein : Unflavoured |
Route of Administration : Oral
Formulation : Plant Based Powered Nutritional Formulation
Dose : 29g (3 heaped scoops) in 500ml of water
Dosage : OD for 3 months
|
| Comparator Agent |
None |
None |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically healthy Physically Active Adults between the ages of 40 and 65 years (both ages and all genders 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
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
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
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)= "41"
Final Enrollment numbers achieved (India)="41" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/07/2022 |
| Date of Study Completion (India) |
19/01/2023 |
| 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
Modification(s)
|
Study Design : Open Label, Prospective, Non-Randomised, Non-Comparative, Two Arm Clinical Study Indication : Plant Based Nutritional Supplement for Clinically Healthy Physically Active Adults Investigational Product Details
Name : Essen Plant Protein : Unflavoured
Route of Administration : Oral
Dose : 29g (3 heaped scoops) in 500ml of water
Dosage : OD for 3 months Name : Essen Plant Protein : Chocolate Flavoured
Route of Administration : Oral
Dose : 35g (6 levelled scoops) in 500ml of water
Dosage : OD for 3 months Subject Population : Clinically healthy adult subjects between the ages of 40 and 65 years (both ages and all genders inclusive) Treatment Arms : Two. Non Comparative Single Arm Study
Treatment Arm I : Unflavoured Essen Plant Protein
Treatment Arm II : Chocolate Flavoured Essen Plant Protein 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. Oral nutritional supplements can be prescribed to supply one or more nutrient deï¬ciencies and restore the proper development and function of the body. The aim of such products is to supplement everyday diet with nutrients in an effort to elevate the health status in adults. Purpose of the Study : Essen Plant Protein is a plant based supplement by Essen Fooddies Pvt. Ltd with key ingredients that have been researched in improving general health in clinically healthy adults. This clinical study is designed as an Open Label, Prospective, Randomised, Non Comparative, Two Arm Clinical Study to Evaluate the Effectiveness, Safety and Tolerability of “Essen Plant Protein†of Essen Fooddies India Pvt. Ltd as a Nutritional Supplement in in physically active Adults. |