Oral Processing and Appetite in Older Adults

January 2, 2023 updated by: Miriam Clegg, University of Reading

The Effect of Dentition, Eating Rate, Oral Processing, and Gastric Emptying on Appetite and Satiety in Older Adults (≥65 Years of Age)

The goal of this observational study is to learn about changes in oral processing and appetite in older adults aged 65+ years old. The main question it aims to answer is if oral processing affects gastric emptying in older adults (≥65 years old).

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

  • To investigate if food intake and satiety differ between faster and slower eaters, within older adults (≥65 years old).
  • To assess if chewing rate, salivary flow rate, oral processing and gastric emptying differ between older adults (≥65 years old) with smaller versus bigger appetites.

Study Type

Observational

Enrollment (Anticipated)

86

Contacts and Locations

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

Study Contact

Study Contact Backup

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

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy adults aged 65 years old or older

Description

Inclusion Criteria:

  • 65 years old or over (no upper age limit);each group will contain an equal number of male and female participants;
  • living sufficiently local to attend the two visits needed;
  • able to understand and communicate in English language.

Exclusion Criteria:

  • Diagnosed dysphagia;
  • (recent) oral surgery that significantly affects eating and/or swallowing;
  • diagnosis of type 1 or type 2 diabetes;
  • participant undergoing current treatment for cancer;
  • participants with zero natural teeth;
  • severe loss of appetite and not able to finish a meal (based on CNAQ) and/or people on special or therapeutic diets that restrict the consumption of a full meal and/or the meals provided;
  • not able to provide informed consent as defined by the T-CogS test (participants with T-CogS < 22 will be excluded);
  • participants having a pacemaker;
  • not able to accept the two meal dishes provided and/or relevant food/ingredient included in the meals allergies or intolerances or aversions;
  • not able to feed themselves.

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

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective appetite assessment: Ad-libitum meal consumption
Time Frame: 20 minutes
Consumption of the ad-libitum meal is measured (g). Participants are instructed to eat until they feel comfortable full
20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective appetite assessment: VAS
Time Frame: Every 30 minutes for 3 hours
Appetite are assessed using a 100 mm Visual Analogue Scales (VAS, scale 0-100)
Every 30 minutes for 3 hours
Gastric Emptying
Time Frame: Samples taken every 15 minutes for 3 hours
Gastric emptying is measured using of 100 microliters of 13C Octanoic Acid breath test
Samples taken every 15 minutes for 3 hours
Chewing rate
Time Frame: At baseline
Chewing rate would be assessed with recording the preload breakfast meal provided and analysing the video recording in software (ELAN 6.4) for number of chews, bites, swallows, time of food in the mouth.
At baseline
Salivary flow rate
Time Frame: At baseline
Stimulated and unstimulated salivary flow rate would be assessed with passive drooling method.
At baseline
BMI
Time Frame: At baseline
BMI is assessed by using a body composition monitor (OMRON Viva)
At baseline
Oral Health
Time Frame: At baseline
Oral Health will be assessed by using an Oral Health Questionnaire
At baseline
Chewing ability
Time Frame: At baseline
Chewing ability will be assessed by using a colour mixing ability chewing gum test (Heu-Check test, University of Bern)
At baseline
Glucose
Time Frame: Every 15 minutes for the first hour after the meal and every 30 minutes thereafter till the end of the total 3 hours
Glucose will be assessed from finger prick blood samples
Every 15 minutes for the first hour after the meal and every 30 minutes thereafter till the end of the total 3 hours
Insulin
Time Frame: Every 15 minutes for the first hour after the meal and every 30 minutes thereafter till the end of the total 3 hours
Insulin will be assessed from finger prick blood samples
Every 15 minutes for the first hour after the meal and every 30 minutes thereafter till the end of the total 3 hours
Salivary a-amylase
Time Frame: At baseline
Salivary a-amylase activity will be assessed from the stimulated saliva collected, by using a-amylase kinetic kit
At baseline

Collaborators and Investigators

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

Sponsor

University of Reading

Collaborators

Queen's University, Belfast
University of Bern
Wageningen University

Investigators

  • Principal Investigator: Miriam Clegg, BSc, PhD, m.e.clegg@reading.ac.uk

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 (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

December 15, 2022

First Submitted That Met QC Criteria

January 2, 2023

First Posted (Actual)

January 4, 2023

Study Record Updates

Last Update Posted (Actual)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 2, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UREC 22/29

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 (unlinked / 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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