Older AdultsNCT04521374
The Effects of Texture Modified Diets on Dietary Intake and Appetite Responses in Older Adults
A study testing Preload meals that are solid or texture modified and are fortified with protein or not fortified with protein in people with Older Adults, run by University of Reading at 1 site in United Kingdom.
Trial summary
This study aims to investigate the effects of equicaloric texture modified and regular meals that are either fortified with protein or not on dietary intake and satiety in older adults (65+) living in the United Kingdom (UK). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adults
- What is being tested?
- Preload meals that are solid or texture modified and are fortified with protein or not fortified with protein
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Sep 2020to 6 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- aged 65 years or over (no upper age limit);
- be within body mass index range (18.5-34.9kg/m2 );
- regularly consume 3 meals a day (breakfast by 11am, lunch and dinner);
- be able to accept test meals provided;
- be able to feed themselves;
- be able to give informed consent; i.e not lacking mental capacity;
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- Have access to a kitchen, freezer and fridge.
- Have access to a telephone.
- understand English.
Who cannot join
- Diagnosed with coronavirus (COVID-19) or have had it in the last 4 weeks.
- have any existing neurological or gastrointestinal condition;
- have Cancer;
- have no current chewing or swallowing difficulties (such as dysphagia);
- have no existing cognitive or psychiatric disorder;
- taking medications that can significantly affect taste changes, appetite or gastric emptying;
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- be on a special or therapeutic diet;
- have any food allergies or intolerances that will be worsened with meals provided in the study;
- have a history of drug or alcohol misuse;
- smoke more than 10 cigarettes a day.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Influence of Texture Modified and Protein-enriched Meals on Dietary Intake and Appetite Responses in Healthy Older Adults
This study aims to investigate the effects of equicaloric texture modified and regular meals that are either fortified with protein or not on dietary intake and satiety in older adults (65+) living in the United Kingdom (UK).
Read the detailed description
- To investigate whether there are any differences in appetite responses following a texture modified meal compared to a standard meal.
- To investigate whether protein-enriched versions of a texture modified meal and/or standard meal affects satiety and subsequent intake in healthy older adults.
- To investigate the effects of a texture modified diet, standard diet and their protein-enriched versions on gastric emptying in healthy older adults.
- Conditions
- Older Adults
- Being tested
- Preload meals that are solid or texture modified and are fortified with protein or not fortified with protein
- Keywords
- Older adults, Texture modified diet, Protein fortification, Appetite, Dietary intake, Food first
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preload meals that are solid or texture modified and are fortified with protein or not fortified with proteinBehavioural
Immediately after consuming the preload meal, volunteers will use a 100mm visual analogue scale (VAS) to rate their liking towards the meal, their hunger, fullness, desire to eat and prospective food intake. Subsequently, they will record these every 30 minutes until they consume their ad-libitum dinner
| Study group | Role | What they receive |
|---|---|---|
| Standard Meal | Experimental | A regular meal (equivalent to International Dysphagia Diet Standardisation Initiative [IDSSI] Level 7) will consist of meat, potatoes and peas: 333kcal, 16g protein. Receives: Behavioral: Preload meals that are solid or texture modified and are fortified with protein or not fortified with protein |
| Standard Protein Fortified Meal | Experimental | A regular meal (equivalent to International Dysphagia Diet Standardisation Initiative [IDSSI] Level 7) will consist of meat, potatoes and peas: 333kcal, 25g protein. Receives: Behavioral: Preload meals that are solid or texture modified and are fortified with protein or not fortified with protein |
| Texture Modified Meal | Experimental | A pureed meal (equivalent to International Dysphagia Diet Standardisation Initiative [IDSSI] Level 4) will consist of meat, potatoes and peas: 340kcal, 16g protein. Receives: Behavioral: Preload meals that are solid or texture modified and are fortified with protein or not fortified with protein |
| Texture Modified Protein Fortified Meal | Experimental | A pureed meal (equivalent to International Dysphagia Diet Standardisation Initiative [IDSSI] Level 4) will consist of meat, potatoes and peas: 350kcal, 25g protein. Receives: Behavioral: Preload meals that are solid or texture modified and are fortified with protein or not fortified with protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intake at ad-libitum dinner
Intake at the ad-libitum meal is measured (grams). Volunteers are instructed to eat only until they feel comfortable satisfied and are given 20 min to consume the meal.
Measured: 4 days in total (one measurement per study day)
Secondary outcomes (2)
Ratings (Appetite, hedonic and palatability) of breakfast, preload lunch and ad-libitum dinner
Appetite, hedonic and palatability ratings are assessed using validated 100 mm Visual Analogue Scales (VAS, sscale 0-100). Before and immediately after breakfast and assessed every 30 min for 360 min
Measured: Regular ratings each study visit, 4 days in total
Gastric emptying
Gastric emptying will be measured using 13C-labelled sodium acetate which will be added into a bottle of water. This will be consumed alongside preload meal. Measurements will be taken every 1 hour after consumption of breakfast up to preload, then every 15 min after the preload for 180 min.
Measured: Regular samples each study visit, 4 days in total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start7 Sep 2020
- Primary completion30 Apr 2022
- Study completion6 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Older AdultsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 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
- Investigators
- Lisa Methven, BSc, PhD, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04521374
- Sponsor's protocol ID
- UREC 19/68
- Status last verified
- Oct 2022
- First submitted
- 7 Aug 2020
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No personal identification data will be shared. The study is not under an obligation to share data, however, it is possible that some of the individual (unliked / non identifiable) data will be useful in a meta-analysis and, hence sharing individual participant data (IPD) will be considered.
Publications
Wright L, Cotter D, Hickson M, Frost G. Comparison of energy and protein intakes of older people consuming a texture modified diet with a normal hospital diet. J Hum Nutr Diet. 2005 Jun;18(3):213-9. doi: 10.1111/j.1365-277X.2005.00605.x.
PubMed 15882384Pritchard SJ, Davidson I, Jones J, Bannerman E. A randomised trial of the impact of energy density and texture of a meal on food and energy intake, satiation, satiety, appetite and palatability responses in healthy adults. Clin Nutr. 2014 Oct;33(5):768-75. doi: 10.1016/j.clnu.2013.10.014. Epub 2013 Oct 25.
PubMed 24200201Keller H, Chambers L, Niezgoda H, Duizer L. Issues associated with the use of modified texture foods. J Nutr Health Aging. 2012 Mar;16(3):195-200. doi: 10.1007/s12603-011-0160-z.
PubMed 22456772Volkert D, Beck AM, Cederholm T, Cruz-Jentoft A, Goisser S, Hooper L, Kiesswetter E, Maggio M, Raynaud-Simon A, Sieber CC, Sobotka L, van Asselt D, Wirth R, Bischoff SC. ESPEN guideline on clinical nutrition and hydration in geriatrics. Clin Nutr. 2019 Feb;38(1):10-47. doi: 10.1016/j.clnu.2018.05.024. Epub 2018 Jun 18.
PubMed 30005900Cichero JAY. Age-Related Changes to Eating and Swallowing Impact Frailty: Aspiration, Choking Risk, Modified Food Texture and Autonomy of Choice. Geriatrics (Basel). 2018 Oct 12;3(4):69. doi: 10.3390/geriatrics3040069.
PubMed 31011104
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Influence of Texture Modified and Protein-enriched Meals on Dietary Intake and Appetite Responses in Healthy Older Adults
- ClinicalTrials.gov ID
- NCT04521374
- Acronym / sponsor ID
- UREC 19/68
- Conditions
- Older Adults
- Keywords
- Older adults, Texture modified diet, Protein fortification, Appetite, Dietary intake, Food first
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 6 Sep 2022 (actual)
- First posted
- 20 Aug 2020 (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 investigate the effects of equicaloric texture modified and regular meals that are either fortified with protein or not on dietary intake and satiety in older adults (65+) living in the United Kingdom (UK).
Detailed description
- To investigate whether there are any differences in appetite responses following a texture modified meal compared to a standard meal.
- To investigate whether protein-enriched versions of a texture modified meal and/or standard meal affects satiety and subsequent intake in healthy older adults.
- To investigate the effects of a texture modified diet, standard diet and their protein-enriched versions on gastric emptying in healthy older adults.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard Meal | Experimental | Behavioral: Preload meals that are solid or texture modified and are fortified with protein or not fortified with proteinA regular meal (equivalent to International Dysphagia Diet Standardisation Initiative [IDSSI] Level 7) will consist of meat, potatoes and peas: 333kcal, 16g protein. |
| Standard Protein Fortified Meal | Experimental | Behavioral: Preload meals that are solid or texture modified and are fortified with protein or not fortified with proteinA regular meal (equivalent to International Dysphagia Diet Standardisation Initiative [IDSSI] Level 7) will consist of meat, potatoes and peas: 333kcal, 25g protein. |
| Texture Modified Meal | Experimental | Behavioral: Preload meals that are solid or texture modified and are fortified with protein or not fortified with proteinA pureed meal (equivalent to International Dysphagia Diet Standardisation Initiative [IDSSI] Level 4) will consist of meat, potatoes and peas: 340kcal, 16g protein. |
| Texture Modified Protein Fortified Meal | Experimental | Behavioral: Preload meals that are solid or texture modified and are fortified with protein or not fortified with proteinA pureed meal (equivalent to International Dysphagia Diet Standardisation Initiative [IDSSI] Level 4) will consist of meat, potatoes and peas: 350kcal, 25g protein. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- aged 65 years or over (no upper age limit);
- be within body mass index range (18.5-34.9kg/m2 );
- regularly consume 3 meals a day (breakfast by 11am, lunch and dinner);
- be able to accept test meals provided;
- be able to feed themselves;
Key exclusion criteria (10 listed)
- Diagnosed with coronavirus (COVID-19) or have had it in the last 4 weeks.
- have any existing neurological or gastrointestinal condition;
- have Cancer;
- have no current chewing or swallowing difficulties (such as dysphagia);
- have no existing cognitive or psychiatric disorder;
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 |
|---|---|---|
| Preload meals that are solid or texture modified and are fortified with protein or not fortified with proteinImmediately after consuming the preload meal, volunteers will use a 100mm visual analogue scale (VAS) to rate their liking towards the meal, their hunger, fullness, desire to eat and prospective food intake. Subsequently, they will record these every 30 minutes until they consume their ad-libitum dinner | Behavioural | Standard Meal, Standard Protein Fortified Meal, Texture Modified Meal, Texture Modified Protein Fortified Meal |
Primary outcome
Intake at ad-libitum dinner
Time frame: 4 days in total (one measurement per study day)
Intake at the ad-libitum meal is measured (grams). Volunteers are instructed to eat only until they feel comfortable satisfied and are given 20 min to consume the meal.
2 secondary outcomes
Ratings (Appetite, hedonic and palatability) of breakfast, preload lunch and ad-libitum dinner
Time frame: Regular ratings each study visit, 4 days in total
Gastric emptying
Time frame: Regular samples each study visit, 4 days in total
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 21 Oct 2022.
- Background: PubMed 15882384Wright L, Cotter D, Hickson M, Frost G. Comparison of energy and protein intakes of older people consuming a texture modified diet with a normal hospital diet. J Hum Nutr Diet. 2005 Jun;18(3):213-9. doi: 10.1111/j.1365-277X.2005.00605.x.
- Background: PubMed 24200201Pritchard SJ, Davidson I, Jones J, Bannerman E. A randomised trial of the impact of energy density and texture of a meal on food and energy intake, satiation, satiety, appetite and palatability responses in healthy adults. Clin Nutr. 2014 Oct;33(5):768-75. doi: 10.1016/j.clnu.2013.10.014. Epub 2013 Oct 25.
- Background: PubMed 22456772Keller H, Chambers L, Niezgoda H, Duizer L. Issues associated with the use of modified texture foods. J Nutr Health Aging. 2012 Mar;16(3):195-200. doi: 10.1007/s12603-011-0160-z.
- Background: PubMed 30005900Volkert D, Beck AM, Cederholm T, Cruz-Jentoft A, Goisser S, Hooper L, Kiesswetter E, Maggio M, Raynaud-Simon A, Sieber CC, Sobotka L, van Asselt D, Wirth R, Bischoff SC. ESPEN guideline on clinical nutrition and hydration in geriatrics. Clin Nutr. 2019 Feb;38(1):10-47. doi: 10.1016/j.clnu.2018.05.024. Epub 2018 Jun 18.
- Background: PubMed 31011104Cichero JAY. Age-Related Changes to Eating and Swallowing Impact Frailty: Aspiration, Choking Risk, Modified Food Texture and Autonomy of Choice. Geriatrics (Basel). 2018 Oct 12;3(4):69. doi: 10.3390/geriatrics3040069.
- Individual participant dataSharing planned: No. No personal identification data will be shared. The study is not under an obligation to share data, however, it is possible that some of the individual (unliked / non identifiable) data will be useful in a meta-analysis and, hence sharing individual participant data (IPD) will be considered.
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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.
Lisa Methven, BSc, PhD principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preload meals that are solid or texture modified and are fortified with protein or not fortified with protein in people with Older Adults, 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 9 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 21 Oct 2022. 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?
Intake at ad-libitum dinner (time frame: 4 days in total (one measurement per study day)). 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 NCT04521374, which also lists 5 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 21 Oct 2022.