Oral Processing and Appetite in Older Adults

Older Adults Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05671003
• Other study ID #: UREC 22/29
• Status: Not yet recruiting
• Start date: January 2023
• Est. completion date: October 2023

Study information

• Verified date: January 2023
• Source: University of Reading
• Contact: Miriam Clegg, BSc, PhD
• Phone: +44 (0)118 378 8723
• Email: m.e.clegg[@]reading.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 86
• Est. completion date: October 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Food Intake
• Older Adults
• Oral Processing

Locations

Country	Name	City	State
United Kingdom	University of Reading	Reading

Sponsors (4)

Lead Sponsor	Collaborator
University of Reading	Queen's University, Belfast, University of Bern, Wageningen University

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

Krop EM, Hetherington MM, Nekitsing C, Miquel S, Postelnicu L, Sarkar A. Influence of oral processing on appetite and food intake - A systematic review and meta-analysis. Appetite. 2018 Jun 1;125:253-269. doi: 10.1016/j.appet.2018.01.018. Epub 2018 Feb 22. — View Citation

Morley JE, Silver AJ. Anorexia in the elderly. Neurobiol Aging. 1988 Jan-Feb;9(1):9-16. doi: 10.1016/s0197-4580(88)80004-6. — View Citation

Pina GMS, Mota Carvalho R, Silva BSF, Almeida FT. Prevalence of hyposalivation in older people: A systematic review and meta-analysis. Gerodontology. 2020 Dec;37(4):317-331. doi: 10.1111/ger.12497. Epub 2020 Sep 23. — View Citation

Tada A, Miura H. Systematic review of the association of mastication with food and nutrient intake in the independent elderly. Arch Gerontol Geriatr. 2014 Nov-Dec;59(3):497-505. doi: 10.1016/j.archger.2014.08.005. Epub 2014 Aug 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective appetite assessment: Ad-libitum meal consumption	Consumption of the ad-libitum meal is measured (g). Participants are instructed to eat until they feel comfortable full	20 minutes
Secondary	Subjective appetite assessment: VAS	Appetite are assessed using a 100 mm Visual Analogue Scales (VAS, scale 0-100)	Every 30 minutes for 3 hours
Secondary	Gastric Emptying	Gastric emptying is measured using of 100 microliters of 13C Octanoic Acid breath test	Samples taken every 15 minutes for 3 hours
Secondary	Chewing rate	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
Secondary	Salivary flow rate	Stimulated and unstimulated salivary flow rate would be assessed with passive drooling method.	At baseline
Secondary	BMI	BMI is assessed by using a body composition monitor (OMRON Viva)	At baseline
Secondary	Oral Health	Oral Health will be assessed by using an Oral Health Questionnaire	At baseline
Secondary	Chewing ability	Chewing ability will be assessed by using a colour mixing ability chewing gum test (Heu-Check test, University of Bern)	At baseline
Secondary	Glucose	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
Secondary	Insulin	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
Secondary	Salivary a-amylase	Salivary a-amylase activity will be assessed from the stimulated saliva collected, by using a-amylase kinetic kit	At baseline