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

October 19, 2022 updated by: Lisa Methven, University of Reading

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
4 days in total (one measurement per study day)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Regular ratings each study visit, 4 days in total
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.
Regular samples each study visit, 4 days in total

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Reading

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lisa Methven, BSc, PhD, University of Reading

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 7, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 6, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UREC 19/68

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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