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CTRI Number  CTRI/2024/03/064441 [Registered on: 19/03/2024] Trial Registered Prospectively
Last Modified On: 15/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effect of high protein supplement on muscle strength, muscle mass and physical function in elderly population. 
Scientific Title of Study   A Prospective, Open label, Randomized, Controlled, Three-Arm, Comparative Study to Determine the Effect of high protein supplement on muscle strength, muscle mass and physical function in elderly population. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NUN-HFD-007/23 Protocol v3.0 22nd February 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanjay Mishra 
Designation  Prinicipal Investigator 
Affiliation  Rumedic Hospital 
Address  Rumedic Hospital, Room No.- 1, Department of general Physician, Rz 52-4/3 Raj Nager Part 1 Street No 9, Old Mehrauli Rd, near Shiv Saktti Mandir, Palam, New Delhi, 110045

South West
DELHI
110045
India 
Phone  8527569065  
Fax    
Email  sanmishra75@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Preeti Chhabra 
Designation  Co-Investigator 
Affiliation  Shri Krishna Super Speciality Institute of Ayurveda 
Address  Room N0.-1, Department of Medicine, Shri Krishna Super Speciality Institute of Ayurveda, 48A, Block C4A, Janakpuri, New Delhi, Delhi, 110058

West
DELHI
110058
India 
Phone  9891008498  
Fax    
Email  drrajchh@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr. Deepti Khanna 
Designation  Clinical Research and Claims Capability Leader, HFD 
Affiliation  Hindustan Unilever Limited 
Address  Hindustan Unilever Limited Nutrition Research and Development Centre Plot Number 67, Sector 32, Gurgaon 122001, Haryana, India

Gurgaon
HARYANA
122001
India 
Phone  911244097100  
Fax    
Email  deepti.khanna2@unilever.com  
 
Source of Monetary or Material Support  
Hindustan Unilever Limited Unilever House, B D Sawant Marg Chakala, Andheri East Mumbai 400099, Maharashtra, India 
 
Primary Sponsor  
Name  Hindustan Unilever Limited 
Address  Hindustan Unilever Limited Nutrition Research and Development Centre Plot Number 67, Sector 32, Gurgaon 122001, Haryana, India 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Preeti Chhabra  Skin, Shri Krishna super specialty, Institute of Ayurveda  48A, Block C4A, Janakpuri, New Delhi, Delhi, 110058
South West
DELHI 		 8527569065

drrajchh@yahoo.com 
Dr Sanjay Mishra  Bensups Hospital  Street No 75, Dwarka Sector 12, Delhi - 110078
South
DELHI 		 9891008498

sanmishra75@gmail.com 
Dr Sanjay Mishra  Rumedic Hospital   Rz 52--4/3 Raj Nager Part 1 Street No 9, Old Mehrauli Rd, near Shiv Saktti Mandir, Palam, New Delhi- 110045
South West
DELHI 		 9891008498

sanmishra75@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Good Society Ethical Research  Approved 
Good Society Ethical Research  Approved 
Good Society Ethical Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  To Determine the Effect of high protein supplement on muscle strength, muscle mass and physical function in elderly population. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Horlicks Strength Plus (30 g P-ONS in 150 ml milk)  30 g P-ONS in 150 ml milk, twice a day (2-3 hours- after breakfast and before dinner) along with lifestyle counselling. Subject will visit at site on Day 1, Day 28, Day 56 and Day 84. 
Intervention  Horlicks Strength Plus (30 g P-ONS in 150 ml water)  30 g P-ONS in 150 ml water, twice a day (2-3 hours- after breakfast and before dinner) along with lifestyle counselling. Subject will visit at site on Day 1, Day 28, Day 56 and Day 84. 
Comparator Agent  Lifestyle Couselling  Total duration of the study is 168 days. Subject will visit at site on Day 1, Day 28, Day 56, Day 84, Day 112, Day 140 and Day 168 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Physically independent mobile men and post menopausal women above or equal to 60 years of age who are able to rise from a seated position to standing will be considered
2.All participants below the cutoff for 30 second Chair Stand test 30CST will be included in the study 30SCST cutoffs more than 9 for men and more than 8 for women to be considered
3.Participants having normal resting blood pressure or stage I hypertension systolic blood pressure BP greater than or equal to greater than or equal to 130 to 139 mmHg diastolic BP greater than or equal 80 to 89 mmHg will be considered
4.Participants having BMI 20 to 32.5 kg per m2 will be considered
5.Participants or diabetics on stable doses of oral hypoglycemic agents OHA for at least the last 3 months with glycated hemoglobin HbA1C less than or equal to 8 percent will be considered
6.Participants with a normal liver function and or kidney function and CBC or abnormal values which are considered clinically non significant as per investigator
7.The potential participant should not be on any structured resistance or aerobic exercise training program in the previous 6 months
8.Participants should be willing and able to follow the study protocol and protocol related procedures to participate in the study
9.Participants who can understand and provide written informed consent to participate in the study
 
 
ExclusionCriteria 
Details  1. Participants who have had significant weight loss or gain in the past 6 months.
2. Participants having history of having cancer, infectious diseases, unstable cardiac, and/or gastrointestinal disease or poorly controlled diabetes or on insulin injections for diabetes or having alterations of dosages of OHA in the last 3 months.
3. Participants who regularly uses non-steroidal anti-inflammatory drugs or anticoagulants.
4. Participant with any known food allergy (particularly milk) or intolerance to any food or beverages.
5. Any participant who has taken part in a clinical trial in the past 90 days.
6. Participants on an unusual diets or special diet, for whatever reason e.g., keto diet or any other high protein diet, low sodium diet, for two weeks prior to receiving any test product and throughout his/her participation in the study will be excluded.
7. Participants who have had any surgery in the past 6 months will be excluded.
8. Potential participants who are related (e.g., husband and wife or brother and sister) or persons living in the same household (e.g., tenants sharing a household) cannot be
recruited together in this study; one of them will be excluded.
9. The participant is an employee of the Sponsor, or site (CRO) conducting the study. The participant(s) must also not be related to any personnel conducting the study.
10. Participants consuming non-vegetarian foods (more than 2 a week) in their habitual diet. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To determine the effect of a protein supplement with lifestyle counselling versus lifestyle counselling alone on muscle strength or physical function on elderly participants after a 12 week period of consumption.   Subject will visit at site on Day 1, Day 28, Day 56, Day 84, Day 112, Day 140 and Day 168 
 
Secondary Outcome  
Outcome  TimePoints 
1. To determine the effect of a protein supplement with lifestyle counselling versus lifestyle counselling alone on muscle strength or physical function on elderly participants after a 24 week & period of consumption.
2. To determine the effect of a protein supplement with lifestyle counselling versus lifestyle counselling alone on muscle mass on elderly participants after 12- & 24-week of consumption.
3. To determine the effect of a protein supplement with lifestyle counselling versus lifestyle counselling alone on dietary intake of elderly participants after 12- & 24-week of consumption.
 		 Subject will visit at site on Day 1, Day 28, Day 56, Day 84, Day 112, Day 140 & Day 168 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   28/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The study is a  randomized, open label, controlled, parallel, three arm study.  One twenty adults men and women aged greater than or equal to 60 years or above with body mass index BMI between 20.0 and 32.5 kg/m2 will be included in the study. Each arm will have 40 participants. The protein supplementation will be given for 24 weeks post randomization. Participants will be divided into 3 equal groups comprising 40 participants each. The 3 groups will be assigned to either of the 3 arms (1, 2, 3) sequenced according to the randomization schedule and subject has to visit at site on Day 1, Day 28, Day 56, Day 84, Day 112, Day 140 and Day 168 .

 
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