Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-27 @ 10:05 PM
Study NCT ID:
NCT05671003
Status:
COMPLETED
Last Update Posted:
2024-07-05
First Post:
2022-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Processing and Appetite in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-02', 'studyFirstSubmitDate': '2022-12-15', 'studyFirstSubmitQcDate': '2023-01-02', 'lastUpdatePostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective appetite assessment: Ad-libitum meal consumption', 'timeFrame': 'During the procedure', 'description': 'Consumption of the ad-libitum meal is measured (g). Participants are instructed to eat until they feel comfortable full'}], 'secondaryOutcomes': [{'measure': 'Subjective appetite assessment: VAS', 'timeFrame': 'During the procedure', 'description': 'Appetite are assessed using a 100 mm Visual Analogue Scales (VAS, scale 0-100)'}, {'measure': 'Gastric Emptying', 'timeFrame': 'During the procedure', 'description': 'Gastric emptying is measured using of 100 microliters of 13C Octanoic Acid breath test'}, {'measure': 'Chewing rate', 'timeFrame': 'During the procedure', 'description': '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.'}, {'measure': 'Salivary flow rate', 'timeFrame': 'During the procedure', 'description': 'Stimulated and unstimulated salivary flow rate would be assessed with passive drooling method.'}, {'measure': 'BMI', 'timeFrame': 'During the procedure', 'description': 'BMI is assessed by using a body composition monitor (OMRON Viva)'}, {'measure': 'Oral Health', 'timeFrame': 'During the procedure', 'description': 'Oral Health will be assessed by using an Oral Health Questionnaire'}, {'measure': 'Chewing ability', 'timeFrame': 'During the procedure', 'description': 'Chewing ability will be assessed by using a colour mixing ability chewing gum test (Heu-Check test, University of Bern)'}, {'measure': 'Glucose', 'timeFrame': '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', 'description': 'Glucose will be assessed from finger prick blood samples'}, {'measure': 'Insulin', 'timeFrame': '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', 'description': 'Insulin will be assessed from finger prick blood samples'}, {'measure': 'Salivary a-amylase', 'timeFrame': 'During the procedure', 'description': 'Salivary a-amylase activity will be assessed from the stimulated saliva collected, by using a-amylase kinetic kit'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['older adults', 'appetite', 'oral processing', 'food intake', 'chewing', 'salivary flow', 'gastric emptying'], 'conditions': ['Older Adults', 'Appetitive Behaviour', 'Food Intake', 'Oral Processing']}, 'referencesModule': {'references': [{'pmid': '25179444', 'type': 'BACKGROUND', '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.'}, {'pmid': '32965067', 'type': 'BACKGROUND', '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.'}, {'pmid': '2898107', 'type': 'BACKGROUND', '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.'}, {'pmid': '29408331', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '* To investigate if food intake and satiety differ between faster and slower eaters, within older adults (≥65 years old).\n* 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy adults aged 65 years old or older', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 65 years old or over (no upper age limit);each group will contain an equal number of male and female participants;\n* living sufficiently local to attend the two visits needed;\n* able to understand and communicate in English language.\n\nExclusion Criteria:\n\n* Diagnosed dysphagia;\n* (recent) oral surgery that significantly affects eating and/or swallowing;\n* diagnosis of type 1 or type 2 diabetes;\n* participant undergoing current treatment for cancer;\n* participants with zero natural teeth;\n* 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;\n* not able to provide informed consent as defined by the T-CogS test (participants with T-CogS \\< 22 will be excluded);\n* participants having a pacemaker;\n* not able to accept the two meal dishes provided and/or relevant food/ingredient included in the meals allergies or intolerances or aversions;\n* not able to feed themselves.'}, 'identificationModule': {'nctId': 'NCT05671003', 'briefTitle': 'Oral Processing and Appetite in Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Reading'}, 'officialTitle': 'The Effect of Dentition, Eating Rate, Oral Processing, and Gastric Emptying on Appetite and Satiety in Older Adults (≥65 Years of Age)', 'orgStudyIdInfo': {'id': 'UREC 22/29'}}, 'contactsLocationsModule': {'locations': [{'city': 'Reading', 'country': 'United Kingdom', 'facility': 'University of Reading', 'geoPoint': {'lat': 51.45625, 'lon': -0.97113}}], 'overallOfficials': [{'name': 'Miriam Clegg, BSc, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'm.e.clegg@reading.ac.uk'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Reading', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Bern', 'class': 'OTHER'}, {'name': 'Wageningen University', 'class': 'OTHER'}, {'name': "Queen's University, Belfast", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Miriam Clegg', 'investigatorAffiliation': 'University of Reading'}}}}