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

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ClinicalTrials.gov Identifier: NCT04521374

Recruitment Status : Recruiting

First Posted : August 20, 2020

Last Update Posted : April 28, 2021

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Sponsor:

Information provided by (Responsible Party):

Lisa Methven, University of Reading

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Older Adults	Behavioral: Preload meals that are solid or texture modified and are fortified with protein or not fortified with protein	Not Applicable

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

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	40 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Single (Participant)
Masking Description:	All samples provided to the participant are labelled with 3 digit random codes
Primary Purpose:	Other
Official Title:	Investigating the Influence of Texture Modified and Protein-enriched Meals on Dietary Intake and Appetite Responses in Healthy Older Adults
Actual Study Start Date :	September 7, 2020
Estimated Primary Completion Date :	September 6, 2021
Estimated Study Completion Date :	September 6, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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.

Secondary Outcome Measures :

Ratings (Appetite, hedonic and palatability) of breakfast, preload lunch and ad-libitum dinner [ Time Frame: 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 [ Time Frame: 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.

Eligibility Criteria

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Ages Eligible for Study:	65 Years and older (Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04521374

Contacts

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Contact: Lisa Methven, BSc, PhD	+44(0)1183788714	l.methven@reading.ac.uk
Contact: Miriam Clegg, BSc, PhD	+44(0)118 378 8723	m.e.clegg@reading.ac.uk

Locations

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United Kingdom
University of Reading	Recruiting
Reading, United Kingdom
Contact: Lisa Methven, MSc, PhD +44(0)1183788714 l.methven@reading.ac.uk
Contact: Miriam Clegg, BSc, PhD +44 (0)118 378 8723 m.e.clegg@reading.ac.uk

Sponsors and Collaborators

University of Reading

Investigators

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Principal Investigator:	Lisa Methven, BSc, PhD	University of Reading

More Information

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.

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. Review.

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). pii: E69. doi: 10.3390/geriatrics3040069.

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Responsible Party:	Lisa Methven, : Professor in Food and Sensory Science, University of Reading
ClinicalTrials.gov Identifier:	NCT04521374
Other Study ID Numbers:	UREC 19/68
First Posted:	August 20, 2020 Key Record Dates
Last Update Posted:	April 28, 2021
Last Verified:	April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No
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.

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Lisa Methven, University of Reading:


Older adults Texture modified diet Protein fortification	Appetite Dietary intake Food first

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