Femoral Fragility FracturesNCT05711277
The Taste and Acceptability of a High Protein Ice Cream Compared With Hospital Milkshake Nutritional Supplement
A study testing Standard milkshake ONS (Fortisip Compact Protein) and High protein, fortified, ice cream in people with Femoral Fragility Fractures and Malnutrition, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Femoral Fragility Fractures, Malnutrition
- What is being tested?
- Standard milkshake ONS (Fortisip Compact Protein) and High protein, fortified, ice cream
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jun 2022to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients aged 65 years and over admitted to QMC hospital.
- 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.
Who cannot join
- Patients < 65 years old.
- 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).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queens Medical Centre
Nottingham, Nottinghamshire, NG7 2UH
About this study
Official title: 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
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.
Read the 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:
- 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.
- Participants will be randomly allocated to receive either:
- 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).
- 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
- Femoral Fragility Fractures, Malnutrition
- Being tested
- Standard milkshake ONS (Fortisip Compact Protein), High protein, fortified, ice cream
- Keywords
- Older adults, Malnutrition, Oral Nutritional Supplements, Fractures, Frailty, Dietary intake
- Medical subject headings
- Malnutrition, Fractures, Bone, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard milkshake ONS (Fortisip Compact Protein)Dietary supplement
Also called ONS, Sip feeds, Oral nutritional supplements
Two 125ml bottles of standard ONS administered a day for two days
High protein, fortified, ice creamDietary supplement
Also called N-ICE CREAM, Nottingham-Ice cream
Two 80g servings of N-ICE CREAM administered a day for two days
| Study group | Role | What they receive |
|---|---|---|
| N-ICE CREAM | Experimental | Not described Receives: Dietary Supplement: High protein, fortified, ice cream |
| Milkshake ONS | Active comparator | Not described Receives: Dietary Supplement: Standard milkshake ONS (Fortisip Compact Protein) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of acceptability by questionnaire (taste, texture, aroma, consistency etc).
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.
Measured: 4 days
Evaluation of product preference
A single question questionnaire used to ask patients whether they preferred Nottingham-Ice cream or the milkshake oral nutritional supplement.
Measured: 4 days
Secondary outcomes (3)
Evaluation of compliance
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.
Measured: 4 days
Attitudes towards long term use of milkshake oral nutritional supplement and Nottingham-Ice cream by questionnaire
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.
Measured: 4 days
Feasibility of having Nottingham-Ice cream at home
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.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start20 Jun 2022
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Fragility FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711277
- Sponsor's protocol ID
- 22HC002
- Status last verified
- Feb 2023
- First submitted
- 23 Sep 2022
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05711277
- Acronym / sponsor ID
- 22HC002
- Conditions
- Femoral Fragility Fractures, Malnutrition
- Keywords
- Older adults, Malnutrition, Oral Nutritional Supplements, Fractures, Frailty, Dietary intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Participants will be randomly allocated to receive either:
- 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).
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-ICE CREAM | Experimental | Dietary Supplement: High protein, fortified, ice cream |
| Milkshake ONS | Active comparator | Dietary Supplement: Standard milkshake ONS (Fortisip Compact Protein) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patients aged 65 years and over admitted to QMC hospital.
- 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.
Key exclusion criteria (7 listed)
- Patients < 65 years old.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard milkshake ONS (Fortisip Compact Protein)Also: ONS, Sip feeds, Oral nutritional supplementsTwo 125ml bottles of standard ONS administered a day for two days | Dietary supplement | Milkshake ONS |
| High protein, fortified, ice creamAlso: N-ICE CREAM, Nottingham-Ice creamTwo 80g servings of N-ICE CREAM administered a day for two days | Dietary supplement | N-ICE CREAM |
Primary outcome
Evaluation of acceptability by questionnaire (taste, texture, aroma, consistency etc).
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.
Evaluation of product preference
Time frame: 4 days
A single question questionnaire used to ask patients whether they preferred Nottingham-Ice cream or the milkshake oral nutritional supplement.
3 secondary outcomes
Evaluation of compliance
Time frame: 4 days
Attitudes towards long term use of milkshake oral nutritional supplement and Nottingham-Ice cream by questionnaire
Time frame: 4 days
Feasibility of having Nottingham-Ice cream at home
Time frame: 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard milkshake ONS (Fortisip Compact Protein) and High protein, fortified, ice cream in people with Femoral Fragility Fractures and Malnutrition, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of acceptability by questionnaire (taste, texture, aroma, consistency etc). (time frame: 4 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.