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

Not Applicable

Completed

• Conditions: Older Adults
• Interventions: Behavioral: Preload meals that are solid or texture modified and are fortified with protein or not fortified with protein

• Registration Number: NCT04521374
• Lead Sponsor: University of Reading

Brief 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).

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 Timeline

• Study First Submitted: 2020-08-07
• Study First Submitted QC: 2020-08-18
• Study First Posted: 2020-08-20
• Study Start: 2020-09-07
• Primary Completion: 2022-04-30
• Study Completion: 2022-09-06
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-19
• Last Update Posted: 2022-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Intake at ad-libitum dinner	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.

Secondary Outcome Measures

Name	Time	Method
Ratings (Appetite, hedonic and palatability) of breakfast, preload lunch and ad-libitum dinner	Regular ratings each study visit, 4 days in total	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
Gastric emptying	Regular samples each study visit, 4 days in total	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.

Trial Locations

Locations (1)

University of Reading; 🇬🇧 Reading, United Kingdom