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

Older Adults Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04521374
• Other study ID #: UREC 19/68
• Status: Completed
• Phase: N/A
• Start date: September 7, 2020
• Est. completion date: September 6, 2022

Study information

• Verified date: October 2022
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 6, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Older Adults

Intervention

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

Locations

Country	Name	City	State
United Kingdom	University of Reading	Reading

Sponsors (1)

Lead Sponsor	Collaborator
University of Reading

Country where clinical trial is conducted

United Kingdom, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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