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)
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).
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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Reading | Reading |
Lead Sponsor | Collaborator |
---|---|
University of Reading | Queen's University, Belfast, University of Bern, Wageningen University |
United Kingdom,
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
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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