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

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).

Study Overview

• Status: Completed
• Conditions: Older Adults
• Intervention / Treatment: Behavioral: Preload meals that are solid or texture modified and are fortified with protein or not fortified with protein

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Reading, United Kingdom
    • University of Reading

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Standard Meal; 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; 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
EXPERIMENTAL: Standard Protein Fortified Meal; 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; 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
EXPERIMENTAL: Texture Modified Meal; 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; 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
EXPERIMENTAL: Texture Modified Protein Fortified Meal; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Reading
• Investigators: Principal Investigator: Lisa Methven, BSc, PhD, University of Reading

Publications and helpful links

General 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.
• Pritchard 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.
• Keller 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.
• Volkert 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.
• Cichero 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 7, 2020
• Primary Completion (ACTUAL): April 30, 2022
• Study Completion (ACTUAL): September 6, 2022

Study Registration Dates

• First Submitted: August 7, 2020
• First Submitted That Met QC Criteria: August 18, 2020
• First Posted (ACTUAL): August 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 21, 2022
• Last Update Submitted That Met QC Criteria: October 19, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Older adults; Appetite; Dietary intake; Texture modified diet; Protein fortification; Food first
• Other Study ID Numbers: UREC 19/68

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No