NCT04521374

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 20, 2020

Completed
18 days until next milestone

Study Start

First participant enrolled

September 7, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2022

Completed
Last Updated

October 21, 2022

Status Verified

October 1, 2022

Enrollment Period

1.6 years

First QC Date

August 7, 2020

Last Update Submit

October 19, 2022

Conditions

Keywords

Older adultsTexture modified dietProtein fortificationAppetiteDietary intakeFood first

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Ratings (Appetite, hedonic and palatability) of breakfast, preload lunch and ad-libitum dinner

    Regular ratings each study visit, 4 days in total

  • Gastric emptying

    Regular samples each study visit, 4 days in total

Study Arms (4)

Standard Meal

EXPERIMENTAL

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

Standard Protein Fortified Meal

EXPERIMENTAL

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

Texture Modified Meal

EXPERIMENTAL

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

Texture Modified Protein Fortified Meal

EXPERIMENTAL

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

Interventions

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

Standard MealStandard Protein Fortified MealTexture Modified MealTexture Modified Protein Fortified Meal

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Reading

Reading, United Kingdom

Location

Related Publications (5)

  • 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.

    PMID: 15882384BACKGROUND
  • 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.

    PMID: 24200201BACKGROUND
  • 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.

    PMID: 22456772BACKGROUND
  • 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.

    PMID: 30005900BACKGROUND
  • 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.

    PMID: 31011104BACKGROUND

MeSH Terms

Interventions

Proteins

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

  • Lisa Methven, BSc, PhD

    University of Reading

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
All samples provided to the participant are labelled with 3 digit random codes
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
: Professor in Food and Sensory Science

Study Record Dates

First Submitted

August 7, 2020

First Posted

August 20, 2020

Study Start

September 7, 2020

Primary Completion

April 30, 2022

Study Completion

September 6, 2022

Last Updated

October 21, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

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.

Locations