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NCT Number: NCT05671003

Oral Processing and Appetite in Older Adults

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).

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Key information

Conditions

Older Adults Appetitive Behaviour Food Intake Oral Processing

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Reading

Reading, United Kingdom

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Objective appetite assessment: Ad-libitum meal consumption

    Time frame: During the procedure

    Consumption of the ad-libitum meal is measured (g). Participants are instructed to eat until they feel comfortable full

Secondary outcomes

  1. Subjective appetite assessment: VAS

    Time frame: During the procedure

    Appetite are assessed using a 100 mm Visual Analogue Scales (VAS, scale 0-100)

  2. Gastric Emptying

    Time frame: During the procedure

    Gastric emptying is measured using of 100 microliters of 13C Octanoic Acid breath test

  3. Chewing rate

    Time frame: During the procedure

    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.

  4. Salivary flow rate

    Time frame: During the procedure

    Stimulated and unstimulated salivary flow rate would be assessed with passive drooling method.

  5. BMI

    Time frame: During the procedure

    BMI is assessed by using a body composition monitor (OMRON Viva)

  6. Oral Health

    Time frame: During the procedure

    Oral Health will be assessed by using an Oral Health Questionnaire

  7. Chewing ability

    Time frame: During the procedure

    Chewing ability will be assessed by using a colour mixing ability chewing gum test (Heu-Check test, University of Bern)

  8. Glucose

    Time frame: During the procedure. 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

  9. Insulin

    Time frame: During the procedure. 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

  10. Salivary a-amylase

    Time frame: During the procedure

    Salivary a-amylase activity will be assessed from the stimulated saliva collected, by using a-amylase kinetic kit

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Collaborators

  • Queen's University, Belfast
  • University of Bern
  • Wageningen University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 4, 2023
Registry last updated
Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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