The Effects of Texture Modified Diets on Dietary Intake and Appetite Responses in Older Adults

Study Overview
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Brief Summary
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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
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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.

Official Title
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Investigating the Influence of Texture Modified and Protein-enriched Meals on Dietary Intake and Appetite Responses in Healthy Older Adults

Conditions
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Older Adults

Intervention / Treatment
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* Behavioral: Preload meals that are solid or texture modified and are fortified with protein or not fortified with protein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; Have access to a kitchen, freezer and fridge. Have access to a telephone. understand English. Exclusion Criteria: 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; 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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard Meal<br>A regular meal (equivalent to International Dysphagia Diet Standardisation Initiative [IDSSI] Level 7) will consist of meat, potatoes and peas: 333kcal, 16g protein. | Behavioral: Preload meals that are solid or texture modified and are fortified with protein or not fortified with protein<br>* 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<br>|
| Experimental: Standard Protein Fortified Meal<br>A regular meal (equivalent to International Dysphagia Diet Standardisation Initiative [IDSSI] Level 7) will consist of meat, potatoes and peas: 333kcal, 25g protein. | Behavioral: Preload meals that are solid or texture modified and are fortified with protein or not fortified with protein<br>* 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<br>|
| Experimental: Texture Modified Meal<br>A pureed meal (equivalent to International Dysphagia Diet Standardisation Initiative [IDSSI] Level 4) will consist of meat, potatoes and peas: 340kcal, 16g protein. | Behavioral: Preload meals that are solid or texture modified and are fortified with protein or not fortified with protein<br>* 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<br>|
| Experimental: Texture Modified Protein Fortified Meal<br>A pureed meal (equivalent to International Dysphagia Diet Standardisation Initiative [IDSSI] Level 4) will consist of meat, potatoes and peas: 350kcal, 25g protein. | Behavioral: Preload meals that are solid or texture modified and are fortified with protein or not fortified with protein<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 days in total (one measurement per study day) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Regular samples each study visit, 4 days in total | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Older adults, Texture modified diet, Protein fortification, Appetite, Dietary intake, Food first