The RELISH Study: Compliance and Palatability of Oral Nutritional Supplements in Hospitalised Older Adults

NCT ID: NCT05620082

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-22
• Study Completion Date: 2025-02-04

Brief Summary

The RELISH study will investigate a new oral nutritional supplement (fortified porridge) for older adults in hospital who are undernourished (i.e., have malnutrition). Malnutrition is a lack of nutritional intake that can lead to poor recovery from illness, increasing hospital length of stay, and elevating healthcare costs. 22% of hospitalised older adults are estimated to have malnutrition. Oral nutritional supplementation (ONS) is key in the management of malnutrition. ONS are energy and nutrient dense products designed to increase dietary intake when diet alone is insufficient to meet daily nutritional requirements. However, for the ONS to be effective they need to be palatable (i.e., taste good), so that patients consume them (i.e., have good compliance) to reap the benefits of extra calories and protein. Normally, hospital patients are offered liquid based ONS (sip feeds). However, previous research has pinpointed that 56% of older adults on geriatric wards did not like sip feeds. Hence, exploration of compliance to different ONS formats is an important research direction to maximise malnourished older adult's nutritional intake. Therefore, the current study aimed to investigate the compliance and palatability of novel fortified porridge compared to traditional sip-feeds in malnourished older adults in hospital.

Detailed Description

22% of hospitalised older adults are estimated to be in a state of malnutrition. Malnutrition, also known as undernutrition, is a lack of nutritional intake leading to decreased fat free mass and diminished physiological functioning. Malnutrition impairs patient recovery, increasing hospital length of stay and escalating healthcare costs. Therefore, the identification and management of malnutrition is a vital patient-centred outcome to enhance older adult's health and quality of life and to enable cost-effective treatment and care.

A key method to support individualised nutritional care of hospital in-patients is the use of oral nutritional supplementation (ONS). ONS are energy and nutrient dense products designed to increase dietary intake when diet alone is insufficient to meet daily nutritional requirements. Overall, research suggests favourable impacts of ONS on nutritional status and healthcare costs, while the impact on functional outcomes and mortality are more controversial. A burgeoning evidence base attests to the importance of considering acceptability and compliance of ONS on adequate intake and thus effectiveness of ONS in practice.

Patient compliance to ONS considers the relationship between the amount of ONS prescribed and the amount of ONS ingested and is important to maximise clinical and cost-effectiveness. Palatability refers to the hedonic (i.e., pleasantness) evaluation of sensory factors, such as taste and smell, leading to alterations in food or fluid consumption. Supplemental preference may be affected by a multitude of factors such as taste, colour, smell, after taste and texture. Typically, hospital patients are offered liquid based ONS (sip feeds). However, previous research has pinpointed that 56% of older adults on geriatric wards did not like sip feeds. Hence, exploration of compliance to different ONS formats is an important research direction to maximise malnourished older adult's nutritional intake.

Malnourished hospitalised older adults should be offered an improved range and provision of ONS to suit patient preferences and maximise intake. For instance, an attractive alternative strategy is the use of energy and protein-dense meals (via fortification) or snacks (supplementation), including fortified bread, protein-enriched main meals and between meal snacks, such as biscuits, yoghurt and ice cream. Yet this is an understudied area, with limited data investigating compliance to alternative ONS products compared to ready-made drinks in hospital, such as powdered ONS and snacks, or their clinical effectiveness. Therefore, the current study aimed to investigate the compliance and palatability of novel fortified porridge compared to traditional sip-feeds in malnourished hospitalised older adults.

Research questions include:

1. What are the compliance rates (% intake) of fortified porridge compared to standard liquid based ONS in malnourished hospitalised older adults?

2. What are the palatability ratings (e.g., taste) of fortified porridge compared to standard liquid based ONS in malnourished hospitalised older adults?

3. What is the acceptability of fortified porridge compared to standard liquid based ONS in malnourished hospitalised older adults, including facilitators and barriers to their use on medical wards?

A mixed methods randomised controlled crossover design will be conducted to determine compliance and palatability of fortified porridge in malnourished hospitalised older adults compared to a liquid-based control ONS. The acceptability of products will be assessed through qualitative interviews to explore patients and healthcare professionals' experiences and views of using the nutritional supplements. Participants will be prescribed ONS twice per day for 4 days, in addition to normal meals, in a crossover design. The products will be offered in-between breakfast and lunch, and after dinner to reduce the detrimental long period of calorie absence experienced overnight.

Conditions

Malnutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

New fortified porridge, then drink-based control

Participants will first be given a new fortified porridge (Adams Vital Nutrition Ltd. High Protein Oats, 157g, 230kcal, 15g protein) twice per day for the first 2 days, in addition to normal meals in-between breakfast and lunch, and after dinner. Then given a drink-based control supplement (125g, 306kcal, 18g protein) for the next 2 days.

Group Type: EXPERIMENTAL

Standard liquid-based oral nutritional supplement

Intervention Type: DIETARY_SUPPLEMENT

An anonymous ready-made drink supplement: 125g, 306kcal, 18.3g protein.

Fortified porridge

Intervention Type: DIETARY_SUPPLEMENT

Vital Daily High Protein Oats (Adams Vital Nutrition Ltd.): 157g, 230kcal, 15g protein.

Health care professionals

Health care professionals working on the wards receiving the intervention, including nurses, dietetics team, and health care assistants were interviewed to explore acceptability of products.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Drink-based control, then new fortified porridge

Participants will be given an anonymous drink-based control supplement twice per day for the first 2 days, in addition to normal meals, in-between breakfast and lunch, and after dinner. Then given a new fortified porridge supplement (157g, 230kcal, 15g protein) for the next 2 days.

Group Type: EXPERIMENTAL

Standard liquid-based oral nutritional supplement

Intervention Type: DIETARY_SUPPLEMENT

An anonymous ready-made drink supplement: 125g, 306kcal, 18.3g protein.

Fortified porridge

Intervention Type: DIETARY_SUPPLEMENT

Vital Daily High Protein Oats (Adams Vital Nutrition Ltd.): 157g, 230kcal, 15g protein.

Interventions

Standard liquid-based oral nutritional supplement

An anonymous ready-made drink supplement: 125g, 306kcal, 18.3g protein.

Intervention Type: DIETARY_SUPPLEMENT

Fortified porridge

Vital Daily High Protein Oats (Adams Vital Nutrition Ltd.): 157g, 230kcal, 15g protein.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Older adults ≥65 years
• Patients on University Hospital Southampton (UHS) acute medical wards
• Medium-high risk of malnutrition (MUST score 1-4)
• Able to provide written consent

Exclusion Criteria

• Patients that have used ONS in previous month
• Receiving enteral or parental nutrition
• Patients with a MUST score >4 (severely malnourished)
• Patients with a BMI ≤15
• Patients with chronic liver disease, renal failure, dysphagia
• Patients who have had major surgery within the preceding month
• Patients with a terminal illness
• Patients receiving end of life care
• Patients unable to eat by mouth (Nil By Mouth [NBM])
• Patients who require alternative ONS as advised by dietetic support

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Southampton NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samantha J Meredith, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southampton

Locations

University Hospital Southanmpton NHS Foundation Trust

Southampton, Hampshire, United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

RHM MED1921

Identifier Type: -

Identifier Source: org_study_id