Older AdultsNCT05671003
Oral Processing and Appetite in Older Adults
An observational study of Older Adults and Appetitive Behaviour, run by University of Reading at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adults, Appetitive Behaviour, Food Intake
- How many people
- 88 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jan 2023to 15 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Healthy adults aged 65 years old or older
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Older Adults, Appetitive Behaviour, Food Intake, Oral Processing
- Keywords
- older adults, appetite, oral processing, food intake, chewing, salivary flow, gastric emptying
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During the procedure
Secondary outcomes (10)
Subjective appetite assessment: VAS
Appetite are assessed using a 100 mm Visual Analogue Scales (VAS, scale 0-100)
Measured: During the procedure
Gastric Emptying
Gastric emptying is measured using of 100 microliters of 13C Octanoic Acid breath test
Measured: During the procedure
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.
Measured: During the procedure
Salivary flow rate
Stimulated and unstimulated salivary flow rate would be assessed with passive drooling method.
Measured: During the procedure
BMI
BMI is assessed by using a body composition monitor (OMRON Viva)
Measured: During the procedure
Oral Health
Oral Health will be assessed by using an Oral Health Questionnaire
Measured: During the procedure
Chewing ability
Chewing ability will be assessed by using a colour mixing ability chewing gum test (Heu-Check test, University of Bern)
Measured: During the procedure
Glucose
Glucose will be assessed from finger prick blood samples
Measured: 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
Insulin will be assessed from finger prick blood samples
Measured: 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
Salivary a-amylase
Salivary a-amylase activity will be assessed from the stimulated saliva collected, by using a-amylase kinetic kit
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start15 Jan 2023
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern, Wageningen University, Queen's University, Belfast
- Responsible party
- Principal investigator, Miriam Clegg, University of Reading
- Investigators
- Miriam Clegg, BSc, PhD, Principal investigator, m.e.clegg@reading.ac.uk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05671003
- Sponsor's protocol ID
- UREC 22/29
- Status last verified
- Jul 2024
- First submitted
- 15 Dec 2022
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 25179444Pina 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.
PubMed 32965067Morley JE, Silver AJ. Anorexia in the elderly. Neurobiol Aging. 1988 Jan-Feb;9(1):9-16. doi: 10.1016/s0197-4580(88)80004-6.
PubMed 2898107Krop 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.
PubMed 29408331
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dentition, Eating Rate, Oral Processing, and Gastric Emptying on Appetite and Satiety in Older Adults (≥65 Years of Age)
- ClinicalTrials.gov ID
- NCT05671003
- Acronym / sponsor ID
- UREC 22/29
- Conditions
- Older Adults, Appetitive Behaviour, Food Intake, Oral Processing
- Keywords
- older adults, appetite, oral processing, food intake, chewing, salivary flow, gastric emptying
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- University of Bern, Wageningen University, Queen's University, Belfast
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Healthy adults aged 65 years old or older
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
10 secondary outcomes
Subjective appetite assessment: VAS
Time frame: During the procedure
Gastric Emptying
Time frame: During the procedure
Chewing rate
Time frame: During the procedure
Salivary flow rate
Time frame: During the procedure
BMI
Time frame: During the procedure
Oral Health
Time frame: During the procedure
Chewing ability
Time frame: During the procedure
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
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
Salivary a-amylase
Time frame: During the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Background: PubMed 25179444Tada 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.
- Background: PubMed 32965067Pina 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.
- Background: PubMed 2898107Morley JE, Silver AJ. Anorexia in the elderly. Neurobiol Aging. 1988 Jan-Feb;9(1):9-16. doi: 10.1016/s0197-4580(88)80004-6.
- Background: PubMed 29408331Krop 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miriam Clegg, BSc, PhD principal investigator
m.e.clegg@reading.ac.uk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Older Adults and Appetitive Behaviour, run by University of Reading at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective appetite assessment: Ad-libitum meal consumption (time frame: During the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05671003, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.