MalnutritionNCT03176030
Fortified Foods in Older Inpatients
An observational study of Malnutrition and Dementia, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Malnutrition in older inpatients is a significant problem espicially among those with dementia. A number of methods have been used to tackle this issue and oral nutritional supplements (ONS) were proven to be the most effective way. Read more about this study
- Who is it for?
- Ages 70 to 100 years
- Conditions the study is for
- Malnutrition, Dementia, Aging
- What is being tested?
- Fortified Foods
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2017to 31 Mar 2018
- Phase
- Observational
- 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 70 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Eligible patients will be female and male older patients who are admitted to acute medical wards for older people in two hospitals.
Who may be able to join
- Both female and male participants in each hospital.
- Patients aged 70 years and above including those who have dementia and frailty.
Who cannot join
- Patients receiving enteral tube feeding or parenteral nutrition
- Patients with a known food allergy, eating disorder or illness, which requires a therapeutic diet incompatible with fortification.
- Patients who are receiving end of life care.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Fortified Foods Improve Energy and Protein Intake in Older People Whilst in Hospital? A Pilot Study
Malnutrition in older inpatients is a significant problem espicially among those with dementia. A number of methods have been used to tackle this issue and oral nutritional supplements (ONS) were proven to be the most effective way. However, they are limited by their poor tolerability due to lack of familiarity with these products. An alternative method is to fortify familiar food with protein, energy and micronutrient. thus, the aim of this study to test the feasibility and acceptability of delivering fortified foods to older patients whilst in hospital including those with dementia and frailty. This pilot study will compare the daily protein and energy intake in older people before and after offering fortified food. Furthermore, patients' likeability and staff acceptability of these fortified foods will be assessed.
Read the detailed description
Malnutrition is a significant problem amongst hospitalised older people, and can impede effective recovery. Oral nutritional supplements (ONS) are limited by their poor tolerability and an alternative strategy is food fortification, the addition of protein/energy/micronutrients to frequently eaten food. The aim of this pilot study is to establish the feasibility and acceptability of delivering fortified foods to older people including those who have dementia and frailty whilst in hospital and to assess whether fortified foods could increase the energy and protein intake.
This is a quasi-experimental study on acute medical wards for older inpatient in two UK hospitals, with a before and after comparison. The intervention involves the provision of additional between-meal fortified foods (enhanced with protein, energy, and micronutrients) and meal supplementation. Daily energy and protein intake will be assessed for three consecutive days during the baseline period and then in the intervention period. Likeability of fortified food and food choices (the number, type, and frequency of fortified foods consumed) will be examined. Likeability of fortified food by patients will be assessed using likeability scales. Interviews or focus groups will be conducted with staff to assess the acceptability of fortified food. Costs related to developing, packing and delivering the fortified foods will be calculated.
The findings of this pilot study will identify whether delivering fortified food is feasible in acute elderly care wards, which foods are preferred and their acceptability. The results will inform the design of a definitive clinical trial.
- Conditions
- Malnutrition, Dementia, Aging, Frail Elderly Syndrome
- Being tested
- Fortified Foods
- Medical subject headings
- Malnutrition, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fortified FoodsDietary supplement
The intervention under study is the provision of between-meal fortified foods (enhanced with protein, energy, and micronutrients) and meal supplementation where meals are poorly consumed. Foods will include both savory and sweet foods with different flavors. Foods will be matched as closely as possible in protein and energy and are calculated to provide typically 210 kcal and 5g protein per item. The volume / weight of the foods are standardized to be of relatively small portion size, such as 100 ml for ice-creams, 40 g for cakes and biscuits, and 100 ml for soup. Some of the products will be supplemented with micronutrients particularly needed by older adults, such as Vitamins (C, D, folic acid, B2, B6) and calcium at one third of the Dietary Reference Values (DRV) per portion. The aim is to achieve a daily consumption of two additional fortified food items.
| Study group | Role | What they receive |
|---|---|---|
| Fortified foods | Fortified foods will be delivered to this group for 3 consecutive days mainly on a mid-meal trolley three times a day (between breakfast and lunch around 10am, between lunch and dinner around 3 pm, and in the evening). However, fortified foods will be available 24 hours and patients will be encouraged to order as many as they like anytime during the day. Receives: Dietary Supplement: Fortified Foods | |
| Baseline | Prior to implementing the intervention, dietary intake among eligible patients offered the standard hospital menu will be measured on the study wards for 24 hours during three days in each of the study wards to estimate the energy and protein intake. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily energy and protein intake
Daily dietary intake will be assessed on three days during both the baseline and intervention periods using visual assessment. each food or meal will be weighed before serving and once the patient has finished using calibrated scales. In addition, a photograph of each plate of food will be taken before and after consumption for each eligible patient. At the end of each meal, the proportion of uneaten (leftover) food will be recorded in quartiles (0%, 25%, 50%, 75%, or 100%) for each component
Measured: 3 consecutive months
Feasibility of delivering fortified foods
The number, type, and frequency of fortified foods chosen by eligible patients during the intervention period will be recorded. This will be done by using a food chart with images. Thus data will be collected on the type of foods (ice-creams, biscuits, soups or cakes) chosen, flavors preferred by individual patients initially and repeat choices, the number of foods chosen each time and at which time of the day.
Measured: 3 days intervention period
Patient's likeability of fortified foods
A 9-point likeability scale will be completed for each eligible patient to test likeability of fortified foods after each meal or snack time during the intervention period.
Measured: 3 days intervention period
Secondary outcomes (1)
Acceptability of fortified food
A purposive sample staff (nursing staff, catering staff and volunteers) involved in the delivery of fortified foods from the study wards in both hospitals will be invited to take part in interviews or focus groups. Participants will be recruited until theoretical saturation has been met; a total sample of approximately 15-20 staff members across the two settings is anticipated to be adequate.
Measured: within 4 weeks of completing the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start1 Sep 2017 (estimated)
- Primary completion31 Mar 2018 (estimated)
- Study completion31 Mar 2018 (estimated)
Why it stopped: Study team submitted IRAS form and the ethic committee advised that this pilot study is more service evaluation and no REC ethical approval was required.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176030
- Sponsor's protocol ID
- RHM MED1428
- Status last verified
- Sep 2018
- First submitted
- 16 May 2017
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data will be shared unless requested directly from authors
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Fortified Foods Improve Energy and Protein Intake in Older People Whilst in Hospital? A Pilot Study
- ClinicalTrials.gov ID
- NCT03176030
- Acronym / sponsor ID
- RHM MED1428
- Conditions
- Malnutrition, Dementia, Aging, Frail Elderly Syndrome
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study team submitted IRAS form and the ethic committee advised that this pilot study is more service evaluation and no REC ethical approval was required.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 1 Sep 2017 (estimated)
- Primary completion
- 31 Mar 2018 (estimated)
- Study completion
- 31 Mar 2018 (estimated)
- First posted
- 5 Jun 2017 (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.
Malnutrition in older inpatients is a significant problem espicially among those with dementia. A number of methods have been used to tackle this issue and oral nutritional supplements (ONS) were proven to be the most effective way. However, they are limited by their poor tolerability due to lack of familiarity with these products. An alternative method is to fortify familiar food with protein, energy and micronutrient. thus, the aim of this study to test the feasibility and acceptability of delivering fortified foods to older patients whilst in hospital including those with dementia and frailty. This pilot study will compare the daily protein and energy intake in older people before and after offering fortified food. Furthermore, patients' likeability and staff acceptability of these fortified foods will be assessed.
Detailed description
Malnutrition is a significant problem amongst hospitalised older people, and can impede effective recovery. Oral nutritional supplements (ONS) are limited by their poor tolerability and an alternative strategy is food fortification, the addition of protein/energy/micronutrients to frequently eaten food. The aim of this pilot study is to establish the feasibility and acceptability of delivering fortified foods to older people including those who have dementia and frailty whilst in hospital and to assess whether fortified foods could increase the energy and protein intake.
This is a quasi-experimental study on acute medical wards for older inpatient in two UK hospitals, with a before and after comparison. The intervention involves the provision of additional between-meal fortified foods (enhanced with protein, energy, and micronutrients) and meal supplementation. Daily energy and protein intake will be assessed for three consecutive days during the baseline period and then in the intervention period. Likeability of fortified food and food choices (the number, type, and frequency of fortified foods consumed) will be examined. Likeability of fortified food by patients will be assessed using likeability scales. Interviews or focus groups will be conducted with staff to assess the acceptability of fortified food. Costs related to developing, packing and delivering the fortified foods will be calculated.
The findings of this pilot study will identify whether delivering fortified food is feasible in acute elderly care wards, which foods are preferred and their acceptability. The results will inform the design of a definitive clinical trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fortified foods | – | Dietary Supplement: Fortified FoodsFortified foods will be delivered to this group for 3 consecutive days mainly on a mid-meal trolley three times a day (between breakfast and lunch around 10am, between lunch and dinner around 3 pm, and in the evening). However, fortified foods will be available 24 hours and patients will be encouraged to order as many as they like anytime during the day. |
| Baseline | – | –Prior to implementing the intervention, dietary intake among eligible patients offered the standard hospital menu will be measured on the study wards for 24 hours during three days in each of the study wards to estimate the energy and protein intake. |
Who may qualify
- Ages
- 70 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Eligible patients will be female and male older patients who are admitted to acute medical wards for older people in two hospitals.
Key inclusion criteria (2 listed)
- Both female and male participants in each hospital.
- Patients aged 70 years and above including those who have dementia and frailty.
Key exclusion criteria (3 listed)
- Patients receiving enteral tube feeding or parenteral nutrition
- Patients with a known food allergy, eating disorder or illness, which requires a therapeutic diet incompatible with fortification.
- Patients who are receiving end of life care.
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 |
|---|---|---|
| Fortified FoodsThe intervention under study is the provision of between-meal fortified foods (enhanced with protein, energy, and micronutrients) and meal supplementation where meals are poorly consumed. Foods will include both savory and sweet foods with different flavors. Foods will be matched as closely as possible in protein and energy and are calculated to provide typically 210 kcal and 5g protein per item. The volume / weight of the foods are standardized to be of relatively small portion size, such as 100 ml for ice-creams, 40 g for cakes and biscuits, and 100 ml for soup. Some of the products will be supplemented with micronutrients particularly needed by older adults, such as Vitamins (C, D, folic acid, B2, B6) and calcium at one third of the Dietary Reference Values (DRV) per portion. The aim is to achieve a daily consumption of two additional fortified food items. | Dietary supplement | Fortified foods |
Primary outcome
Daily energy and protein intake
Time frame: 3 consecutive months
Daily dietary intake will be assessed on three days during both the baseline and intervention periods using visual assessment. each food or meal will be weighed before serving and once the patient has finished using calibrated scales. In addition, a photograph of each plate of food will be taken before and after consumption for each eligible patient. At the end of each meal, the proportion of uneaten (leftover) food will be recorded in quartiles (0%, 25%, 50%, 75%, or 100%) for each component
Feasibility of delivering fortified foods
Time frame: 3 days intervention period
The number, type, and frequency of fortified foods chosen by eligible patients during the intervention period will be recorded. This will be done by using a food chart with images. Thus data will be collected on the type of foods (ice-creams, biscuits, soups or cakes) chosen, flavors preferred by individual patients initially and repeat choices, the number of foods chosen each time and at which time of the day.
Patient's likeability of fortified foods
Time frame: 3 days intervention period
A 9-point likeability scale will be completed for each eligible patient to test likeability of fortified foods after each meal or snack time during the intervention period.
1 secondary outcome
Acceptability of fortified food
Time frame: within 4 weeks of completing the intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Individual participant dataSharing planned: No. No data will be shared unless requested directly from authors
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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?
An observational study of Malnutrition and Dementia, run by University Hospital Southampton NHS Foundation 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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 7 Sep 2018. 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 was withdrawn before enrolling participants, so there are no results.
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?
Daily energy and protein intake (time frame: 3 consecutive months). The study lists 3 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 7 Sep 2018.