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Trials / Completed

CompletedNCT05711277

The Taste and Acceptability of a High Protein Ice Cream Compared With Hospital Milkshake Nutritional Supplement

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
50 (actual)
Sponsor
Nottingham University Hospitals NHS Trust · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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: 1. Patients will be assessed for inclusion and exclusion criteria by the research team, and then provided with information about the study. Patients eligible to take part will be asked for written informed consent or nominated consultee consent sought from patients without capacity. Participant demographics and medical history will be collected from online hospital systems and medical notes. 2. Participants will be randomly allocated to receive either: 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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTStandard milkshake ONS (Fortisip Compact Protein)Two 125ml bottles of standard ONS administered a day for two days
DIETARY_SUPPLEMENTHigh protein, fortified, ice creamTwo 80g servings of N-ICE CREAM administered a day for two days

Timeline

Start date
2022-06-20
Primary completion
2022-09-01
Completion
2022-09-01
First posted
2023-02-02
Last updated
2023-02-10

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT05711277. Inclusion in this directory is not an endorsement.