Skip to main content
Clinical Trials/NCT04521374
NCT04521374CompletedNot Applicable

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

University of Reading1 site in 1 country21 target enrollmentStarted: September 7, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
21
Locations
1
Primary Endpoint
Intake at ad-libitum dinner

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
Single (Participant)

Masking Description

All samples provided to the participant are labelled with 3 digit random codes

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

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.

Intervention: Preload meals that are solid or texture modified and are fortified with protein or not fortified with protein (Behavioral)

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.

Intervention: Preload meals that are solid or texture modified and are fortified with protein or not fortified with protein (Behavioral)

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.

Intervention: Preload meals that are solid or texture modified and are fortified with protein or not fortified with protein (Behavioral)

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.

Intervention: Preload meals that are solid or texture modified and are fortified with protein or not fortified with protein (Behavioral)

Outcomes

Primary Outcomes

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 Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lisa Methven

: Professor in Food and Sensory Science

University of Reading

Study Sites (1)

Loading locations...

Similar Trials