NCT06832488

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 18, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

July 29, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2025

Completed
Last Updated

December 12, 2025

Status Verified

December 1, 2025

Enrollment Period

2 months

First QC Date

February 13, 2025

Last Update Submit

December 4, 2025

Conditions

Keywords

Older adultsFood intakeFood textureEating rateCare homesAppetite

Outcome Measures

Primary Outcomes (1)

  • 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)

    1 day for each diet

Secondary Outcomes (3)

  • Food and energy intake of each meal

    Up to 30 minutes for each meal

  • Eating rate

    Up to 30 minutes for each meal

  • Self-reported appetite and meal liking ratings

    2 minutes before and 2 minutes after each meal

Study Arms (2)

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

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

Behavioral: Diet

Interventions

DietBEHAVIORAL

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

Day 1 receiving easier to eat food textures and day 8 receiving more difficult to eat texturesDay 1 receiving more difficult to eat food textures and day 8 receiving easier to eat textures

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)
  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Reading

Reading, United Kingdom

Location

MeSH Terms

Conditions

Malnutrition

Interventions

Diet

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 13, 2025

First Posted

February 18, 2025

Study Start

July 29, 2025

Primary Completion

September 25, 2025

Study Completion

September 25, 2025

Last Updated

December 12, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Pseudoanonymised data or fully anonymised data will be shared with other researchers.

Locations