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

NCT05620082 | Completed Results DMC

• 1 other identifier: RHM MED1921
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition

Keywords

Malnutrition; Oral nutritional supplementation; Compliance; Palatability; Older adult

Outcome Measures

Primary Outcomes (4)

• Percentage of the Mean Oral Nutritional Supplement Consumed Per Day (%)

  Compliance to oral nutritional supplementation. Leftovers will be weighed (g) using weighing scales (Seca Model 875 digital weighing scale).

  Measured daily during the 4 day testing period

• Energy (kcal) Consumed

  The average amount of daily energy consumed for each nutritional supplement (kcal)

  Measured daily during the 4 day testing period

• Protein Intake (g)

  The average daily amount of protein consumed from nutritional supplements (g)

  Measured daily during the 4 day testing period

• Palatability of Oral Nutritional Supplement

  Palatability ratings, including appearance, smell, taste, sweetness, texture, thickness, aftertaste, mouth feel, and overall likability were assessed with a 7-point hedonic Likert scale (7 = definitely like, 6 = moderately like, 5 = mildly like, 4 = neither like nor dislike, 3 = mildly dislike, 2 = moderately dislike, 1 = definitely dislike).

  Measured at baseline

Secondary Outcomes (1)

• Total Caloric Intake (kcal)

  Completed daily during the 4 day testing period and 2 days before testing (baseline).

Study Arms (3)

New fortified porridge, then drink-based control

EXPERIMENTAL

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.

Dietary Supplement: Standard liquid-based oral nutritional supplement; Dietary Supplement: Fortified porridge

Health care professionals

NO INTERVENTION

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.

Drink-based control, then new fortified porridge

EXPERIMENTAL

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.

Dietary Supplement: Standard liquid-based oral nutritional supplement; Dietary Supplement: Fortified porridge

Interventions

Standard liquid-based oral nutritional supplement DIETARY_SUPPLEMENT

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

Drink-based control, then new fortified porridge; New fortified porridge, then drink-based control

Fortified porridge DIETARY_SUPPLEMENT

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

Drink-based control, then new fortified porridge; New fortified porridge, then drink-based control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead

Study Sites (1)

University Hospital Southanmpton NHS Foundation Trust

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Malnutrition; Patient Compliance

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Dr Samantha J Meredith
• Organization: University of Southampton

s.j.meredith@soton.ac.uk

0238120

Study Officials

• Samantha J Meredith, PhD

  University of Southampton

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 17, 2022
• Study Start: April 22, 2024
• Primary Completion: December 23, 2024
• Study Completion: February 4, 2025
• Last Updated: June 12, 2025
• Results First Posted: June 12, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)