Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05620082 |
| Other study ID # |
RHM MED1921 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 22, 2024 |
| Est. completion date |
January 1, 2025 |
Study information
| Verified date |
May 2024 |
| Source |
University Hospital Southampton NHS Foundation Trust |
| Contact |
Samantha J Meredith, PhD |
| Phone |
+442381206131 |
| Email |
s.j.meredith[@]soton.ac.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
