MalnutritionNCT06832488
Food Texture, Eating Rate and Food Intake in Care Home Older Adults.
A study testing Diet in people with Malnutrition, run by University of Reading at 1 site in United Kingdom.
Trial summary
It's estimated that around 1 in 10 older adults are malnourished or at risk of malnutrition in the UK. In comparison with the general older adult population, care home residents are more likely to be underweight. Many factors can affect food intake and choices of older adults. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- What is being tested?
- Diet
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Jul 2025to 25 Sep 2025
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Care homes:
- Care or residential homes, that host older adult residents that are not in end-of-life care or have solely nursing needs
- Participants:
- Aged 65+
- Permanent care home residents, living in the care home for at least one month
- Able to provide consent or if not having capacity to consent to have a consultee that can provide consent (noting that residents without capacity to consent will be asked for their assent)
Show all 11Show fewer
- Able to consume a "regular" care home diet
- Not on any special diet (i.e., for dysphagia, kidney disease etc.)
- Able to consume at least 1 meal a day
- Not being critically ill or on end-of-life care
- Not allergic or intolerant or dislike completely any foods or ingredients in the meals provided
Who cannot join
- Care homes:
- That solely provide nursing or end-of-life care
- Participants:
- Aged <65 years
- Not living in a care home or living in the care home for less than one month
- Not able to provide consent either by themselves or by a consultee
Show all 10Show fewer
- Under a special diet and/or not able to consume a "regular" care home diet
- Not able to consume at least 1 meal a day
- Being critically ill/end of life care
- Having allergies/intolerances/aversions to ingredients and foods of the meals provided
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Control Trial Exploring the Effect of Food Textures on Food Intake and Eating Rate in Care Home Dwelling Older Adults.
It's estimated that around 1 in 10 older adults are malnourished or at risk of malnutrition in the UK. In comparison with the general older adult population, care home residents are more likely to be underweight. Many factors can affect food intake and choices of older adults. The previous studies of this PhD project have shown that 1) older adults who eat slower, consume less food and 2) that there are food textures that are consumed at a significantly faster pace than others. Following these results, this research will specifically aim to test if providing meals including food textures that require reduced oral processing can increase eating rate and total food intake in care home dwelling older adults. The potential benefits of this research is to inform how providing appropriate food textures can increase older adults (dwelling in care homes) eating speed, ease oral processing and consequently improve food intake, which can help towards better overall health and quality of life.
Participants will be asked to take part in two study days, one week apart. On the one day they will consume all meals including textures that require reduced oral processing ("easier" food textures), and on the other day all meals including textures that require increased oral processing ("more difficult" food textures). The meals will be balanced for energy content per portion, and all foods will be within the normal range of foods provided in care homes. The researchers will record food and energy intake from each meal, duration of meal and calculate eating rate of each meal.
The research will be recruiting from care homes around England, who have reviewed and agreed will all parts of the research. Participants who consume a regular diet can be included.
Read the detailed description
The hypothesis of this study is that consumption of all-meals of a study day with food textures that require reduced oral processing versus food textures that require increased oral processing, would lead to increased total daily food and energy intake in care home older adults. The null hypothesis is that the two study days will no differ in food intake and the alternative hypothesis is that the study day with food textures that require increased oral processing will lead to increased food and energy intake..
Study design: This study includes two study days with a one week washout in between them. In one study day all meals of the day will be provided in "more difficult" to eat textures (a diet with food textures that require increased oral processing). In the other study day all meals of the day will be provided in "easier" to eat textures (a diet with food textures that require reduced oral processing). All meals will be prepared and provided by Apetitio Limited, a food company that specialises in designing and delivering foods for older adults. Some options will be provided by the research team following retail purchase (i.e., biscuits, cakes, bread etc.) All meals, recipes, snacks will be to kept consistent across care homes. The time each participant is starting each meal and the time finishing each meal will be recorded, to calculate total eating time. The weight of the food provided and the weight of the food when finished the meal will also be recorded to calculate food intake, and then using the eating time the eating rate of the meal will be calculated. With residents that are able to using rating scales, short questions on appetite, hunger and liking of the meal will be asked before and after each main meal (breakfast, lunch, evening meal). Same snacks and fluid types will be provided in both study days and the snack and fluid intake will be recorded. No other changes in the daily life of the participant will happen. Baseline information from each participant will be collected before the start of the study from the care homes' records.
The above study design and methodology was influenced by previous research that measured eating rate and food intake in similar ways. At the same time, the methods we will use in this study have been selected carefully to be feasible in care homes and minimise effort needed from the participants and carers.
Food/plate waste measurement (in an audit form): To the residents that are not part of the trial, the meals will also be offered as one of the options on each daily menu. From these meals, and in a fully anonymised way, the researchers will collect the total amount of meals leaving the kitchen and the total leftovers/food waste are being thrown away in order to collect the total amount of these meals consumed and the number of the meals. Data will not be identifiable to the individual. These extra data will be collected to support power and study findings, but will not require consent as no individual is participating in the study, this is purely an "audit" of food served and wasted.
The timetable for the stages of the research is as follows: The researchers aim to run the research around spring-summer 2025. Results will be analysed on completion of the study across care homes. Anonymised results will be then published as a scientific paper and will be presented in international conferences (November 2025- May 2026). Results of this study will also be part of the PhD thesis of the student which will be submitted on or before April 2026.
Recruitment will take place initially at a care home level, where the care home manager has reviewed and consented for the care home to participate in the research. Subsequently, care homes' staff will assist with recruiting eligible participants.
The research itself as well as the presence of the researcher in the care home may influence participants behaviour; however this will be consistent in both study days, which will have a week washout period. The randomised order of the study days in each care home will also possibly affect the results; however the researchers will aim to balanced within each care home, if big enough to have more than one units/dining areas and will be considered in the statistical analysis as well.
To define the sample size, power calculations were undertaken through an online power calculator (ClinCalc, 2024), using a two study groups design, continuous primary endpoint, 80% power and alpha <0.05. The calculations, following the primary outcome of the study, were based on previous, published research in free living older adults when compared energy intake in a meal with or without added sauce and found significant differences in the food intake from the meal with sauce(Best and Appleton, 2011). Sample size has been calculated as 28 participants, and accounting for 10% dropouts to 31 participants.
Participants will be approached through the care home staff and will be provided with the participant information leaflet and consent form. If participants don't have capacity to consent, a consultee will be advised and provided the participant information leaflet and consultee consent form
- Conditions
- Malnutrition
- Being tested
- Diet
- Keywords
- Older adults, Food intake, Food texture, Eating rate, Care homes, Appetite
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietBehavioural
To compare the total food and energy intake of the diet with textures that require reduced oral processing versus the diet with textures that require increased oral processing by measuring weight before and after consumption of each meal and snack
| Study group | Role | What they receive |
|---|---|---|
| Day 1 receiving easier to eat food textures and day 8 receiving more difficult to eat textures | Active comparator | In this arm participants will receive in the first intervention day the easier to eat food textures and in the second (day 8 after washout) the more difficult to eat food textures Receives: Behavioral: Diet |
| Day 1 receiving more difficult to eat food textures and day 8 receiving easier to eat textures | Active comparator | In this arm participants will receive in the first intervention day the more difficult to eat food textures and in the second (day 8 after washout) the easier to eat food textures Receives: Behavioral: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total daily food and energy intake
To compare the total food and energy intake of the meals with textures that require reduced oral processing (day with easier to eat textures) versus the meals with textures that require increased oral processing (day with more difficult to eat texts)
Measured: 1 day for each diet
Secondary outcomes (3)
Food and energy intake of each meal
To compare the food and energy intake of each meal of the day that have meals with textures that require reduced oral processing versus the days that have meals with textures that require increased oral processing.
Measured: Up to 30 minutes for each meal
Eating rate
To compare the eating rate of the meals with textures that require reduced oral processing versus the meals with textures that require increased oral processing.
Measured: Up to 30 minutes for each meal
Self-reported appetite and meal liking ratings
(Where applicable) To assess and compare the self-reported ratings of appetite, fullness and liking of the meals.
The decision tree approach will be followed and the questions and answers structure follows the publication of Pouyet et al. 2015, Food Quality and Preference
A 5-point scale system will be used for answers where (1) is the maximum value and (5) the minimum value
e.g Asking about HUNGER BEFORE THE MEAL
- Are you hungry right now?
- Yes
- Moderately (3)
- No 1a. If yes, how hungry?
- Extremely hungry (1)
- Hungry (2) 1b. If no, how not hungry?
- Not hungry (4)
- Extremely not hungry (5)
- Extremely hungry, (2) Moderately hungry (3) Neither hungry nor not hungry (4) Moderately not hungry (5) Extremely not hungry
Measured: 2 minutes before and 2 minutes after each meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start29 Jul 2025
- Primary completion25 Sep 2025
- Study completion25 Sep 2025
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Methven, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832488
- Sponsor's protocol ID
- IRAS 346597
- Status last verified
- Dec 2025
- First submitted
- 13 Feb 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pseudoanonymised data or fully anonymised data will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Control Trial Exploring the Effect of Food Textures on Food Intake and Eating Rate in Care Home Dwelling Older Adults.
- ClinicalTrials.gov ID
- NCT06832488
- Acronym / sponsor ID
- IRAS 346597
- Conditions
- Malnutrition
- Keywords
- Older adults, Food intake, Food texture, Eating rate, Care homes, Appetite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- 29 Jul 2025 (actual)
- Primary completion
- 25 Sep 2025 (actual)
- Study completion
- 25 Sep 2025 (actual)
- First posted
- 18 Feb 2025 (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.
It's estimated that around 1 in 10 older adults are malnourished or at risk of malnutrition in the UK. In comparison with the general older adult population, care home residents are more likely to be underweight. Many factors can affect food intake and choices of older adults. The previous studies of this PhD project have shown that 1) older adults who eat slower, consume less food and 2) that there are food textures that are consumed at a significantly faster pace than others. Following these results, this research will specifically aim to test if providing meals including food textures that require reduced oral processing can increase eating rate and total food intake in care home dwelling older adults. The potential benefits of this research is to inform how providing appropriate food textures can increase older adults (dwelling in care homes) eating speed, ease oral processing and consequently improve food intake, which can help towards better overall health and quality of life.
Participants will be asked to take part in two study days, one week apart. On the one day they will consume all meals including textures that require reduced oral processing ("easier" food textures), and on the other day all meals including textures that require increased oral processing ("more difficult" food textures). The meals will be balanced for energy content per portion, and all foods will be within the normal range of foods provided in care homes. The researchers will record food and energy intake from each meal, duration of meal and calculate eating rate of each meal.
The research will be recruiting from care homes around England, who have reviewed and agreed will all parts of the research. Participants who consume a regular diet can be included.
Detailed description
The hypothesis of this study is that consumption of all-meals of a study day with food textures that require reduced oral processing versus food textures that require increased oral processing, would lead to increased total daily food and energy intake in care home older adults. The null hypothesis is that the two study days will no differ in food intake and the alternative hypothesis is that the study day with food textures that require increased oral processing will lead to increased food and energy intake..
Study design: This study includes two study days with a one week washout in between them. In one study day all meals of the day will be provided in "more difficult" to eat textures (a diet with food textures that require increased oral processing). In the other study day all meals of the day will be provided in "easier" to eat textures (a diet with food textures that require reduced oral processing). All meals will be prepared and provided by Apetitio Limited, a food company that specialises in designing and delivering foods for older adults. Some options will be provided by the research team following retail purchase (i.e., biscuits, cakes, bread etc.) All meals, recipes, snacks will be to kept consistent across care homes. The time each participant is starting each meal and the time finishing each meal will be recorded, to calculate total eating time. The weight of the food provided and the weight of the food when finished the meal will also be recorded to calculate food intake, and then using the eating time the eating rate of the meal will be calculated. With residents that are able to using rating scales, short questions on appetite, hunger and liking of the meal will be asked before and after each main meal (breakfast, lunch, evening meal). Same snacks and fluid types will be provided in both study days and the snack and fluid intake will be recorded. No other changes in the daily life of the participant will happen. Baseline information from each participant will be collected before the start of the study from the care homes' records.
The above study design and methodology was influenced by previous research that measured eating rate and food intake in similar ways. At the same time, the methods we will use in this study have been selected carefully to be feasible in care homes and minimise effort needed from the participants and carers.
Food/plate waste measurement (in an audit form): To the residents that are not part of the trial, the meals will also be offered as one of the options on each daily menu. From these meals, and in a fully anonymised way, the researchers will collect the total amount of meals leaving the kitchen and the total leftovers/food waste are being thrown away in order to collect the total amount of these meals consumed and the number of the meals. Data will not be identifiable to the individual. These extra data will be collected to support power and study findings, but will not require consent as no individual is participating in the study, this is purely an "audit" of food served and wasted.
The timetable for the stages of the research is as follows: The researchers aim to run the research around spring-summer 2025. Results will be analysed on completion of the study across care homes. Anonymised results will be then published as a scientific paper and will be presented in international conferences (November 2025- May 2026). Results of this study will also be part of the PhD thesis of the student which will be submitted on or before April 2026.
Recruitment will take place initially at a care home level, where the care home manager has reviewed and consented for the care home to participate in the research. Subsequently, care homes' staff will assist with recruiting eligible participants.
The research itself as well as the presence of the researcher in the care home may influence participants behaviour; however this will be consistent in both study days, which will have a week washout period. The randomised order of the study days in each care home will also possibly affect the results; however the researchers will aim to balanced within each care home, if big enough to have more than one units/dining areas and will be considered in the statistical analysis as well.
To define the sample size, power calculations were undertaken through an online power calculator (ClinCalc, 2024), using a two study groups design, continuous primary endpoint, 80% power and alpha <0.05. The calculations, following the primary outcome of the study, were based on previous, published research in free living older adults when compared energy intake in a meal with or without added sauce and found significant differences in the food intake from the meal with sauce(Best and Appleton, 2011). Sample size has been calculated as 28 participants, and accounting for 10% dropouts to 31 participants.
Participants will be approached through the care home staff and will be provided with the participant information leaflet and consent form. If participants don't have capacity to consent, a consultee will be advised and provided the participant information leaflet and consultee consent form
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Day 1 receiving easier to eat food textures and day 8 receiving more difficult to eat textures | Active comparator | Behavioral: DietIn this arm participants will receive in the first intervention day the easier to eat food textures and in the second (day 8 after washout) the more difficult to eat food textures |
| Day 1 receiving more difficult to eat food textures and day 8 receiving easier to eat textures | Active comparator | Behavioral: DietIn this arm participants will receive in the first intervention day the more difficult to eat food textures and in the second (day 8 after washout) the easier to eat food textures |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- Care or residential homes, that host older adult residents that are not in end-of-life care or have solely nursing needs
- Aged 65+
- Permanent care home residents, living in the care home for at least one month
- Able to provide consent or if not having capacity to consent to have a consultee that can provide consent (noting that residents without capacity to consent will be asked for their assent)
- Able to consume a "regular" care home diet
Key exclusion criteria (10 listed)
- That solely provide nursing or end-of-life care
- Aged <65 years
- Not living in a care home or living in the care home for less than one month
- Not able to provide consent either by themselves or by a consultee
- Under a special diet and/or not able to consume a "regular" care home diet
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 |
|---|---|---|
| DietTo compare the total food and energy intake of the diet with textures that require reduced oral processing versus the diet with textures that require increased oral processing by measuring weight before and after consumption of each meal and snack | Behavioural | Day 1 receiving easier to eat food textures and day 8 receiving more difficult to eat textures, Day 1 receiving more difficult to eat food textures and day 8 receiving easier to eat textures |
Primary outcome
Total daily food and energy intake
Time frame: 1 day for each diet
To compare the total food and energy intake of the meals with textures that require reduced oral processing (day with easier to eat textures) versus the meals with textures that require increased oral processing (day with more difficult to eat texts)
3 secondary outcomes
Food and energy intake of each meal
Time frame: Up to 30 minutes for each meal
Eating rate
Time frame: Up to 30 minutes for each meal
Self-reported appetite and meal liking ratings
Time frame: 2 minutes before and 2 minutes after each meal
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 12 Dec 2025.
- Individual participant dataSharing planned: No. Pseudoanonymised data or fully anonymised data will be shared with other researchers.
Related trials for Malnutrition
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Active, not recruitingPhase 2
Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
Environmental Enteric Dysfunction (EED), Stunting
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
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 Diet in people with Malnutrition, run by University of Reading 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 11 inclusion and 10 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 12 Dec 2025. 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?
Total daily food and energy intake (time frame: 1 day for each diet). 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 12 Dec 2025.