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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05671003
Other study ID # UREC 22/29
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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