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Effectiveness of “Entrasol Platinum” to improve the nutrition status in older adults

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2022/021
Enrollment
Unknown
Registered
2022-10-06
Start date
2022-12-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Older adults with malnutrition or at risk of malnutrition

Interventions

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 resident

Sponsors

Kalbe Lanka Pvt. Ltd.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Aged above 60 years - Residing in the selected elder’s homes for more than 1 year and planned to stay for another 6 months - Malnourished or at risk of malnutrition (Mini Nutrition Assessment (MNA) score < 11)

Exclusion criteria

Exclusion criteria: - Those with chronic illnesses (Eg: Cardiac failure, stroke, chronic liver disease chronic kidney disease or under dialysis) - Those who are unable to respond to the questionnaire due to communication difficulties ( speech, hearing, and visual impairment) - Those bedridden - Those who are on a special diet (supplements/ tube feed) - Those on an end-of-life care pathway - Those who have no capacity to consent

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.]

Countries

Sri Lanka

Contacts

Public ContactProf. Ranil Jayawardena

Professor in Nutrition

ranil7@gmail.com / ranil@physiol.cmb.ac.lk94-112 695300 [ext: 203/204/205]

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026