Queens Medical Centre
Nottingham, Nottinghamshire, NG7 2UH, United Kingdom
NCT Number: NCT05711277
This study aims to compare the acceptability of a new high protein, fortified, ice cream called Nottingham-Ice cream (N-ICE CREAM) with a standard milkshake-style oral nutritional supplement (ONS); Fortisip Compact Protein in older patients admitted to hospital with fractures who require ONS as part of routine care.
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Notify Me65 year and older
All sexes
Interventional
Not applicable
Nottingham, Nottinghamshire, NG7 2UH, United Kingdom
Older adults admitted to hospital with fractures are often vulnerable to malnutrition. The European Society for Clinical Nutrition and Metabolism guidelines on clinical nutrition and hydration in geriatrics recommend 'older patients with hip fracture shall be offered ONS post-operatively to improve dietary intake and reduce risk of complications'.
As part of routine care at Nottingham University Hospitals (NUH) NHS Trust patients with femoral fragility fractures and vertebrae fractures are prescribed a milkshake style ONS called Fortisip Compact protein twice daily. Poor compliance (amount consumed relative to amount prescribed) to ONS in older adults has been reported in scientific literature with our own research findings reporting 28% compliance to standard milkshake ONS in older trauma and orthopaedic patients. There is a need for an ONS which patients accept and enjoy, of which ice cream has the strong possibility of accomplishing. There few studies to date exploring the potential of ice cream as a nutritional intervention. Ice cream has proven successful improving quality of life and shown favourable among oncological patients with 88% reporting they would rather eat ice cream that conventional nutritional supplements. Furthermore, research in ortho-geriatric patients at NUH showed an increase in energy intake by 41% for those consuming a high energy and protein ice cream. These encouraging results highlight the need for further scientific research to explore ice cream as an ONS.
This study aims to further explore compliance to N-ICE CREAM compared to standard ONS. This is a randomised crossover study. Participants admitted to hospital with hip or spine fractures and requiring ONS for the duration of their hospital stay only as part of routine care will receive N-ICE CREAM for two days and standard ONS for two days in a random order. Participants will complete acceptability and attitudes questionnaire for each product in additional to a questionnaire about the feasibility of having N-ICE CREAM at home. Compliance to each product will also be monitored and preference noted.
Overview of the study:
A. N-ICE CREAM twice a day for two days; N-ICE CREAM tub size approximately 80g (1.96kcal/g, 0.19g protein/g) followed by a standard milkshake based ONS; Fortisip Compact Protein twice a day for two days; serving size 125ml (2.4kcal/g, 0.14g protein/g).
B. A standard milkshake based ONS; Fortisip Compact Protein twice a day for two days followed by N-ICE CREAM twice a day for two days.
The hypothesis is that N-ICE CREAM will be 'as accepted', if not more accepted, than the milkshake ONS. The results from this study will guide future nutritional interventions for older adults admitted to hospital with fractures.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Two 125ml bottles of standard ONS administered a day for two days
Other names: ONS, Sip feeds, Oral nutritional supplements
Two 80g servings of N-ICE CREAM administered a day for two days
Other names: N-ICE CREAM, Nottingham-Ice cream
Time frame: 4 days
Questionnaire used to ask patients to rate sensory characteristics including appearance, taste/flavour, texture/consistency aroma/smell, taste/sweetness from dislike a lot to like a lot. The average of these scores will represent "overall acceptability." Questionnaire to be completed for Nottingham-Ice cream and the milkshake oral nutritional supplement.
Dislike a lot = 1, dislike moderately = 2, dislike a little = 3, like a little = 5, like moderately = 6, like a lot = 7.
Questionnaires will be undertaken on day two and four.
Time frame: 4 days
A single question questionnaire used to ask patients whether they preferred Nottingham-Ice cream or the milkshake oral nutritional supplement.
Time frame: 4 days
Record daily the amount of Nottingham-Ice cream and milkshake oral nutritional supplement consumed by patients compared to the amount prescribed by either weighing waste, or from and estimated recall from patient or nursing staff.
Good compliance = > 80% of being consumed.
Time frame: 4 days
A questionnaire will be used to record confidence, from very unconfident to very confident, in being able to consuming each product over different time periods (two, four and twelve weeks) and maximum dose tolerated. The average score will represent "overall confidence."
Very unconfident = 1, unconfident =2, confident = 4, very unconfident = 5.
Questionnaires will be undertaken on day two and four.
Time frame: 4 days
Patients to complete the 'Nottingham-Ice cream Feasibility at home' questionnaire. Questions will cover freezer accessibility and storage space, likelihood to store Nottingham-Ice cream and preferred ice cream tub size for storage.
Questionnaire to be completed after patients have trialled Nottingham-Ice cream.
Nottingham University Hospitals NHS Trust
Other
Comparison of the Taste and Acceptability of a New Ice Cream Based Supplement (Nottingham-Ice Cream) Compared to Standard Hospital Milkshake Oral Nutritional Supplement in Older Adults in Hospital Who Have Suffered a Broken Bone
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