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DysphagiaNCT07858942

Softer Meals That Impact the Life of the Elderly (SMILE) - Food Intake Study

A study testing Moulded Pureed Meals in people with Dysphagia, run by Singapore Institute of Technology at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Older adults with chewing or swallowing difficulties may require texture-modified diets to reduce the risk of choking and aspiration. However, conventional texture-modified meals may be less visually appealing and may have lower energy and protein content because of the liquid added during pureeing. Read more about this study

Who is it for?
Ages 60 to 90 years
Conditions the study is for
Dysphagia
What is being tested?
Moulded Pureed Meals
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteSingapore
Study dates
9 Mar 2026to 3 May 2026
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 60 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Resident of St. Luke's ElderCare nursing home
  • Aged 60 to 90 years
  • Reports chewing and/or swallowing difficulties
  • Has been consuming a texture-modified diet for at least six months before study enrolment

Who cannot join

  • Currently receiving tube feeding
  • Unable to provide informed consent due to cognitive impairment, where consent cannot be provided by a legally authorised representative
  • Has food allergies, food intolerances or dietary restrictions that prevent consumption of the study meals

Trial locations and contacts

1 site in 1 country.

Singapore1 site
  • Singapore Institute of Technology

    Singapore

Other trials in Singapore

About this study

Official title: Softer Meals That Impact the Life of the Elderly (SMILE)

Older adults with chewing or swallowing difficulties may require texture-modified diets to reduce the risk of choking and aspiration. However, conventional texture-modified meals may be less visually appealing and may have lower energy and protein content because of the liquid added during pureeing. These factors may reduce food intake and increase the risk of poor nutrition.

This study will evaluate whether visually appealing, texture-modified soft meals prepared from familiar Asian foods can improve food and nutrient intake among older adults with chewing or swallowing difficulties. Up to 35 residents aged 60 years and above will be recruited from a nursing home in Singapore. Eligible participants must have reported chewing and/or swallowing difficulties and must have been consuming a texture-modified diet for at least six months.

Read more

The study will be conducted over two weeks. During the first week, participants will receive the nursing home's existing texture-modified menu. During the second week, they will receive soft versions of the same menu items. The soft meals will be prepared using an enzyme gellant and moulded to resemble the appearance of the original foods. The texture of the soft meals will be verified by the nursing home's speech therapist as safe and appropriate for each participant before the meals are served.

Food intake will be assessed at breakfast, lunch and dinner over seven days in each study week. Individual food items will be weighed before and after each meal to determine the amount consumed. Photographs of the food will also be taken before and after consumption to support assessment of intake. The amount of food consumed will be used to estimate participants' energy and nutrient intake.

The primary aim is to compare food intake during the soft-meal week with food intake during the existing-menu week. The study will provide preliminary evidence on whether familiar, visually appealing texture-modified soft meals can improve oral intake among nursing home residents with chewing or swallowing difficulties. The findings may inform future food-service practices for older adults who require texture-modified diets.

Read the detailed description

Texture-modified diets support oral intake in older adults with chewing or swallowing difficulties, but conventional pureeing can reduce visual appeal and nutrient density. Phase 3 of the Softer Meals that Impact the Life of the Elderly (SMILE) study evaluates texture-modified soft meals designed to retain the recognisable appearance of familiar Asian foods.

This is a single-centre, single-group, two-period study conducted in a nursing home in Singapore. Each participant undergoes both the control and intervention conditions and therefore serves as their own comparator. The study comprises two consecutive seven-day periods. During the first period, participants receive the nursing home's existing texture-modified menu. During the second period, participants receive soft-meal versions of the corresponding menu items. The sequence is not randomised because the first period is intended to establish each participant's baseline intake under the nursing home's existing food-service conditions.

The intervention meals are prepared from menu items normally served by the nursing home. Individual meal components, including carbohydrate, protein and vegetable components, are processed separately. An enzyme gellant is incorporated into each processed food component to produce a soft and cohesive structure. The modified components are heated, transferred into food-grade silicone moulds resembling the original foods, allowed to set, unmoulded and plated. This preparation method is intended to retain the visual identity of individual meal components rather than presenting the meal as an indistinguishable puree.

The soft meals are prepared by nursing home kitchen chefs who have been trained by the research team in the use of the enzyme gellant and preparation method. Preparation is undertaken using the nursing home's existing kitchen facilities and equipment. The intervention is therefore designed to assess an approach that could potentially be incorporated into routine institutional food-service operations without specialised food-production equipment.

Before the intervention meals are served, the texture of the soft meals is verified by the nursing home's speech therapist as safe and appropriate for the participating residents. Meals are served through the nursing home's usual food-service arrangements, and nursing staff remain present during mealtimes as part of routine care.

Food intake is measured at breakfast, lunch and dinner on all seven days of each study period. Each food component is weighed separately before it is served using a weighing scale with two-decimal-place precision. After the participant has completed the meal, the remaining amount of each component is weighed using the same procedure. The amount consumed is calculated as the difference between the pre-meal serving weight and the post-meal leftover weight.

Photographs of each meal are taken before and after consumption to support validation of the weighed food records. The photographs document the served and remaining portions and provide a secondary record against which the food-weight measurements can be checked. The photographs are used for intake assessment and are not intended to replace direct weighing.

The nutritional intake associated with each measured food component is estimated by multiplying the amount consumed by the corresponding nutritional composition of that food item. This permits estimation of energy and macronutrient intake, including protein, carbohydrate and fat. Selected micronutrients, including calcium, iron and zinc, may also be estimated where suitable nutritional composition data are available.

Intake from thickened beverages, fruits and snacks outside the defined study meals is excluded from the food intake assessment, apart from afternoon tea where applicable under the study procedures. To minimise the influence of unrecorded intake, caregivers are informed not to provide participants with food from home or other external sources during the two study periods.

Using corresponding menu items across the two periods is intended to reduce variation arising from differences in the types of foods served. Conducting both periods within the same nursing home also allows meal preparation, food-service arrangements and mealtime support to remain as consistent as practicable. However, because the intervention always follows the baseline period, the study does not control for possible period or order effects.

The within-participant comparison is intended to determine whether changing the preparation and presentation of familiar texture-modified foods is associated with differences in measured oral intake and estimated nutrient intake. The study will provide preliminary evidence on the feasibility of producing visually recognisable texture-modified soft meals within a nursing home kitchen and implementing the meals through routine institutional food service. The findings will inform the design of future controlled studies and the development of culturally familiar texture-modified meals for older adults with chewing or swallowing difficulties.

Conditions
Dysphagia
Being tested
Moulded Pureed Meals, Control diet
Keywords
Texture-modified diet, Moulded pureed food, Dysphagia diet, Older adults, Nursing home, International Dysphagia Diet Standardisation Initiative
Medical subject headings
Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Moulded Pureed MealsOther

    Familiar Asian menu items are modified using an enzyme gellant to produce moulded pureed meals. Individual meal components, including carbohydrate, protein and vegetable components, are pureed separately with added liquid and enzyme gellant, heated, and transferred into food-grade silicone moulds resembling the original foods. After setting, the components are unmoulded, plated and served as visually recognisable versions of the corresponding menu items. The meals are prepared by trained nursing home kitchen staff using existing kitchen equipment. Their texture is verified by the nursing home's speech therapist as safe and appropriate for participating residents before serving. Participants receive the moulded pureed meals at breakfast, lunch and dinner for seven consecutive days.

  • Control dietOther

    A control diet, which is the conventional pureed meals are provided.

Study groups in NCT07858942
Study groupRoleWhat they receive
Moulded Pureed Meal InterventionExperimentalParticipants receive the nursing home's existing texture-modified meals during a seven-day baseline period, followed by moulded pureed versions of corresponding menu items during a seven-day intervention period. Individual food components are prepared using an enzyme gellant and food-grade moulds to resemble the original foods. Food intake is measured at breakfast, lunch and dinner by weighing each food component before and after consumption. Each participant serves as their own comparator.
Receives: Other: Moulded Pureed Meals; Other: Control diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Mean Daily Food Intake

    Mean daily food intake will be calculated from breakfast, lunch and dinner consumed during each seven-day study period. Each food component will be weighed before serving and after meal consumption using a weighing scale with two-decimal-place precision. The amount consumed will be calculated as the serving weight minus the weight of the remaining food. Mean daily food intake during the moulded pureed meal period will be compared with mean daily food intake during the baseline existing texture-modified meal period. Food intake will be reported in grams per day.

    Measured: Baseline seven-day period and moulded pureed meal seven-day intervention period

Secondary outcomes (1)
  1. Change in Mean Daily Energy Intake

    Mean daily energy intake will be estimated from the measured amount of each food component consumed and its corresponding nutritional composition. Energy intake will be calculated for breakfast, lunch and dinner across each seven-day period. Mean daily energy intake during the moulded pureed meal period will be compared with mean daily energy intake during the baseline existing texture-modified meal period. Energy intake will be reported in kilocalories per day.

    Measured: Baseline seven-day period and moulded pureed meal seven-day intervention period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2026
  2. Study start9 Mar 2026
  3. Primary completion16 Mar 2026
  4. Study completion3 May 2026

Resources

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
Not applicable
Intervention model
Single group
Model description
Single-group, two-period, within-participant study. Each participant receives the existing texture-modified menu during the baseline period, followed by the corresponding texture-modified soft-meal intervention. Each participant serves as their own comparator.
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07858942
Sponsor's protocol ID
RECAS-0746
Status last verified
Sep 2026
First submitted
10 Sep 2026
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared because the consent obtained from participants does not include sharing participant-level data through a public repository. Study findings will be reported only in aggregated or de-identified form, in accordance with the approved ethics application and institutional data-governance requirements.

Publications

  • Wu XS, Miles A, Braakhuis AJ. Texture-Modified Diets, Nutritional Status and Mealtime Satisfaction: A Systematic Review. Healthcare (Basel). 2021 May 24;9(6):624. doi: 10.3390/healthcare9060624.

    PubMed 34073835
  • Ott A, Senger M, Lotzbeyer T, Gefeller O, Sieber CC, Volkert D. Effects of a Texture-Modified, Enriched, and Reshaped Diet on Dietary Intake and Body Weight of Nursing Home Residents with Chewing and/or Swallowing Problems: An Enable Study. J Nutr Gerontol Geriatr. 2019 Oct-Dec;38(4):361-376. doi: 10.1080/21551197.2019.1628158. Epub 2019 Jun 21.

    PubMed 31223063
  • Pu D, Choi YY, Chan KM, Poon MM. Modifying Puree Meals in Residential Aged Care Facilities: A Multi-Centre Feasibility and Acceptability Study. Geriatrics (Basel). 2021 Nov 5;6(4):108. doi: 10.3390/geriatrics6040108.

    PubMed 34842703

Questions about this trial

What is this clinical trial studying?

A study testing Moulded Pureed Meals in people with Dysphagia, run by Singapore Institute of Technology at 1 site in Singapore.

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 4 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: finished, as of the sponsor's last update on 5 Oct 2026. 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 Singapore. 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?

Change in Mean Daily Food Intake (time frame: Baseline seven-day period and moulded pureed meal seven-day intervention period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07858942, which also lists 3 linked publications.

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 5 Oct 2026.

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