Home » Trials » SLCTR/2022/021
Impact of Entrasol Platinum as an oral nutritional supplement on clinical, nutritional and functional outcomes of older adults with malnutrition or at risk of malnutrition: a randomized placebo-controlled trial
-
SLCTR Registration Number
SLCTR/2022/021
Date of Registration
The date of last modification
Dec 22, 2023
Trial Status
Scientific Title of Trial
Impact of Entrasol Platinum as an oral nutritional supplement on clinical, nutritional and functional outcomes of older adults with malnutrition or at risk of malnutrition: a randomized placebo-controlled trial
Public Title of Trial
Effectiveness of “Entrasol Platinum” to improve the nutrition status in older adults
Disease or Health Condition(s) Studied
Older adults with malnutrition or at risk of malnutrition
Scientific Acronym
None
Public Acronym
None
Brief title
Effectiveness of 'Entrasol Platinum' as an oral nutritional supplement to improve overall nutritional status of elderly in Sri Lanka
Universal Trial Number
U1111-1282-4903
Any other number(s) assigned to the trial and issuing authority
ERC/22 – 005:SLMA
What is the research question being addressed?
Is “Entrasol Platinum” effective as an oral nutritional supplement to fill the nutritional gap in improving clinical, nutritional, and functional outcomes of older adults with malnutrition or at risk of malnutrition in Sri Lanka?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Placebo
Assignment
Parallel
Purpose
Other
Study Phase
Phase 4
Intervention(s) planned
The proposed study will be conducted at four selected residential care facilities registered in the National Secretariat for Elders in the Colombo district. The participants will be permanent residents who have been staying for more than one year at the same elderly care homes. Two parallel study groups will be recruited for the treatment group and the control group from four elders’ homes. Elderly care homes with eligible participants will be listed down. From that list, we are going to randomize two elderly care homes for the treatment group and the other two for the control group. All adult men and women permanently living in the selected elders’ homes will be invited to take part in the research after a brief explanation of the study procedure. All participants will complete a structured assessment for eligibility by the trained research team. The whole residents’ home is the unit of randomization. At the baseline data collection, the institutional care personnel in the treatment group elders’ home will be instructed to provide each participant with a 200 mL serving of study product (Entrasol Platinum, Kalbe Lanka Pvt. Ltd) containing 12 g protein and 247 kcal per serving, in addition to their usual diet in a day for 12 weeks before bedtime. The institutional care personnel in the control group elders’ home will be instructed to provide each participant with 200 mL of water in addition to their usual diet a day for 12 weeks before bedtime. Care personnel will be advised to encourage residents to consume the amount offered but not to force feed the supplement or water. Further, they will be instructed to keep a daily record of the volume left from the daily serving and reasons for refusal throughout the trial. Furthermore, the participants and the care personnel will be clearly instructed not to replace their usual meal with the liquid supplement.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
The number of participants who achieved a 5% weight gain at the end of 12th week in intervention group and control group |
[ 12th week of introducing intervention ] |
Secondary outcome(s)
|
1.
i. Change in anthropometric parameters (Body weight, Body Mass Index (BMI), Mid Upper Arm Circumference (MUAC), Calf Circumference (CC) ii. Mean change in body composition (DXA lean body mass and fat mass, triceps skin fold thickness) iii. Mean change in biochemical parameters (Full Blood Count (FBC), High Sensitivity C-reactive protein (HS-CRP), serum albumin, total cholesterol, serum vitamin D3) iv. Mean change in functional capacity (hand grip strength, muscle strength and Activities of Daily Living (ADL) v. Mean change in frailty (Five fried model indicator) vi. Mean change in respiratory muscle strength [Peak expiratory flow rate (PEFR)] vii. Mean change in systolic and diastolic blood pressure viii. Mean change in energy and macro nutrient intake per day ix. Mean change in cognitive status [Montreal Cognitive Assessment (MoCA)] x. Mean change in physical activity level [International Physical Activity Questionnaire (IPAQ)- Short form] The measurements will be done in the intervention group and the control group |
[ At baseline and 12th week. Body weight, MUAC, hand grip strength, and muscle strength will be measured at 4th week and 12th week. ] |
Target number/sample size
50 (25 in a group)
Countries of recruitment
Sri Lanka
Anticipated start date
2022-12-01
Anticipated end date
2023-04-30
Date of first enrollment
2023-01-23
Date of study completion
2023-08-25
Recruitment status
Complete: follow up complete
Funding source
Kalbe Lanka Pvt. Ltd.
Regulatory approvals
Not approved
Status
Approved
Date of Approval
2022-07-17
Approval number
ERC/22-005
Details of Ethics Review Committee
| Name: | Ethics Review Committee of Sri Lanka Medical Association |
| Institutional Address: | Sri Lanka Medical Association, No 6, Wijerama Mawatha, Colombo 7. |
| Telephone: | 0112 693324 |
| Email: | erc.slma@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Prof. Ranil Jayawardena
Professor in Nutrition
Department of Physiology, Faculty of Medicine, University of Colombo, 25, Kynsey Road, Colombo 08, Sri Lanka
94-112 695300 [ext: 203/204/205]
0718323332
ranil7@gmail.com / ranil@physiol.cmb.ac.lk
Contact Person for Public Queries
Prof. Priyanga Ranasinghe
Professor in Pharmacology
Department of Pharmacology, Faculty of Medicine, University of Colombo, 25, Kynsey Road, Colombo 08, Sri Lanka
0112695300
077 2770202
ranil7@gmail.com / ranil@physiol.cmb.ac.lk
Primary study sponsor/organization
Kalbe Lanka Pvt. Ltd.
321 Galle Rd, Colombo 00400
0774288090
0112 501 026
kanishka.g@kalbesrilanka.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
2023-08-25
Final sample size
Date of first publication
Link to results
Brief summary of results
