Clinical trial NCT04521374: The Effects of Texture Modified Diets on Dietary Intake and Appetite Responses in Older Adults
Official title: Investigating the Influence of Texture Modified and Protein-enriched Meals on Dietary Intake and Appetite Responses in Healthy Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older Adults
Keywords: Older adults
Texture modified diet
Protein fortification
Appetite
Dietary intake
Food first
Lead sponsor: University of Reading
Sponsor class: OTHER
First posted: 2020-08-20
Enrollment: 21
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility 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.

Primary outcomes:
measure: Intake at ad-libitum dinner
timeFrame: 4 days in total (one measurement per study day)
Secondary outcomes:
measure: Ratings (Appetite, hedonic and palatability) of breakfast, preload lunch and ad-libitum dinner
timeFrame: Regular ratings each study visit, 4 days in total
measure: Gastric emptying
timeFrame: Regular samples each study visit, 4 days in total
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: University of Reading
Study officials:
affiliation: University of Reading
name: Lisa Methven, BSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1111/j.1365-277X.2005.00605.x.
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.
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. doi: 10.1007/s12603-011-0160-z.
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.
citation: 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.