| CTRI Number |
CTRI/2025/05/087538 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
23/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nutritional supplement] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Impact of cost-effective, nutritional supplement on body weight, strength and balance among elderly with malnutrition (I-CARE Study) |
|
Scientific Title of Study
|
"Impact of cost-effective, nutritionally optimized supplement on body composition and functional measures: A multicentric randomized trial among older adults at risk of malnutrition (I-CARE Study)" |
| Trial Acronym |
I-CARE Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sucharita S |
| Designation |
Professor |
| Affiliation |
St Johns Medical College |
| Address |
Room 401, Robert Koch Bhavan, St. Johns Medical College, Sarjapur-Marathalli Rd, beside Bank of Baroda, John Nagar, Koramanagala
Bangalore
KARNATAKA
560034
India |
| Phone |
09845392760 |
| Fax |
|
| Email |
sucharita@stjohns.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sucharita S |
| Designation |
Professor |
| Affiliation |
St Johns Medical College |
| Address |
Room 401, Robert Koch Bhavan, St. Johns Medical College, Sarjapur-Marathalli Rd, beside Bank of Baroda, John Nagar, Koramanagala
Bangalore
KARNATAKA
560034
India |
| Phone |
09845392760 |
| Fax |
|
| Email |
sucharita@stjohns.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sucharita S |
| Designation |
Professor |
| Affiliation |
St Johns Medical College |
| Address |
Room 401, Robert Koch Bhavan, St. Johns Medical College, Sarjapur-Marathalli Rd, beside Bank of Baroda, John Nagar, Koramanagala
Bangalore
KARNATAKA
560034
India |
| Phone |
09845392760 |
| Fax |
|
| Email |
sucharita@stjohns.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research (ICMR) |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research (ICMR) |
| Address |
Indian Council of Medical Research Headquarters, AIIMS Campus Temple, Ansari Nagar East, New Delhi, Delhi 110029 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pushpa S Patil |
SDM college of medical sciences and hospital Dharwad |
Department of community medicine, SDM College of Medical Sciences & Hospital Sattur, Dharwad, Karnataka - 580009
Dharwad
KARNATAKA |
9448967691
patilpushpa27@gmail.com |
| Dr Sucharita S |
St Johns Medical College and Hospital |
Room 401, Robert Koch Bhavan, St. Johns Medical College, Sarjapur-Marathalli Rd, beside Bank of Baroda, John Nagar, Koramanagala
Bangalore
KARNATAKA |
08049466301
sucharita@stjohns.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
| Institutional ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Elderly participants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nutritional supplement |
A nutrient-rich snack, in the form of ladoos or a cereal-pulse/oilseed-based mix, will be specifically formulated for the geriatric population. Participants will consume this nutritious snack daily for a duration of six months. |
| Comparator Agent |
Standard of care |
Nutrition counseling and nutritional education |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
elderly participants at risk of malnourishment |
|
| ExclusionCriteria |
| Details |
Participants with known medical conditions leading to weight loss.
Individuals with active cancer currently undergoing therapy.
Participants with altered estimated Glomerular Filtration Rate (eGFR).
Individuals involved in any ongoing studies involving supplementation or interventions that could influence the outcomes of this study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hand grip strength (kG) |
Baseline and post intervention follow up at 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Functional measures including muscle strength and physical performance |
Baseline and post intervention follow up at 6 months |
|
|
Target Sample Size
|
Total Sample Size="230"
Sample Size from India="230"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/06/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Background: There has been drastic change in the structure of the population with tripling of the population 60 years and above. One of the hidden problems among elderly is the growing prevalence of malnutrition and sarcopenia. Objectives Phase 1: To develop nutritional supplement that is acceptable and palatable to the elderly Indian population and Phase 2: To compare the effect of 6-month nutritional supplementation and nutritional education with nutritional education alone on body composition and functional measures among elderly Indians at risk of malnutrition/or malnourished.
Methods: Phase 1: A nutritional supplement in the form of a nutri snacks/ ladoo will be developed. It will be administered to total of number of 50 Elderly. Each participant will consume the supplement every day for 15 days. Following analysis of the data, the supplement will be suitably modified and prepared for the trial phase- phase 2. Phase 2: Elderly participants aged 60 years and above will be recruited from proposed centers and screened using the mini nutritional assessment scale. Participants identified as being at risk for malnutrition/or malnourished will be recruited. A randomized open-labelled trial will be performed for 180 days (6 months).
Expected outcome: The study will result in the creation of a cost-effective, appetizing, and easy-to consume supplemental product that meets the unique dietary requirements of the elderly population. This will enable policymakers at a national level to target the important problems of malnourishment and sarcopenia. |