The Taste and Acceptability of a High Protein Ice Cream Compared With Hospital Milkshake Nutritional Supplement
NCT ID: NCT05711277
Last Updated: 2023-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
50 participants
INTERVENTIONAL
2022-06-20
2022-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Scheduled Intake
NCT02938247
Higher Protein Diet and Exercise for Optimal Weight Loss in Elderly Women
NCT00912210
Protein Intake and Step Reduction in Older Adults
NCT03285737
Can Protein Intake be Increased by Offering Protein-enriched Foods and Drinks?
NCT02141256
The Impact of Plant-based Blends on Skeletal Muscle Protein Synthesis Rates in Older Adults
NCT05917223
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
N-ICE CREAM
High protein, fortified, ice cream
Two 80g servings of N-ICE CREAM administered a day for two days
Milkshake ONS
Standard milkshake ONS (Fortisip Compact Protein)
Two 125ml bottles of standard ONS administered a day for two days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Standard milkshake ONS (Fortisip Compact Protein)
Two 125ml bottles of standard ONS administered a day for two days
High protein, fortified, ice cream
Two 80g servings of N-ICE CREAM administered a day for two days
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients capable of giving informed consent, or if appropriate, participants having a personal consultee able to complete a declaration in favour of the patient participating in the trial.
* Patients with a diagnosed hip or spine fracture requiring ONS as part of the routine nutritional pathway.
* Patients who have had malnutrition risk assessed by the Malnutrition Universal Screening Tool (MUST) and have a MUST score of 0 or 1.
* Patients with an anticipated length of stay ≥ 4 days.
Exclusion Criteria
* Patients scheduled for total parenteral nutrition or tube feeding.
* Patients with a MUST ≥ 2.
* Clinically unstable patients (e.g. in terminal condition end of life situation).
* Patients with medical or dietary contraindication to any feed ingredients (e.g. with known allergies or intolerance to any ingredients in the N-ICE CREAM or FSCP).
* Patients with significant renal impairment (chronic kidney disease stages 4 and 5).
* Any contraindication against nutritional therapy (includes paralytic ileus\< inborn errors of metabolism of nutrients contained in N-ICE CREAM or FSCP).
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nottingham University Hospitals NHS Trust
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Queens Medical Centre
Nottingham, Nottinghamshire, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
22HC002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.