NCT05671003

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 4, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

January 15, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

July 5, 2024

Status Verified

July 1, 2024

Enrollment Period

8 months

First QC Date

December 15, 2022

Last Update Submit

July 2, 2024

Conditions

Keywords

older adultsappetiteoral processingfood intakechewingsalivary flowgastric emptying

Outcome Measures

Primary Outcomes (1)

  • 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

    During the procedure

Secondary Outcomes (10)

  • Subjective appetite assessment: VAS

    During the procedure

  • Gastric Emptying

    During the procedure

  • Chewing rate

    During the procedure

  • Salivary flow rate

    During the procedure

  • BMI

    During the procedure

  • +5 more secondary outcomes

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy adults aged 65 years old or older

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Reading

Reading, United Kingdom

Location

Related Publications (4)

  • 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: 25179444BACKGROUND
  • 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: 32965067BACKGROUND
  • 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: 2898107BACKGROUND
  • 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.

    PMID: 29408331BACKGROUND

Study Officials

  • Miriam Clegg, BSc, PhD

    m.e.clegg@reading.ac.uk

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 15, 2022

First Posted

January 4, 2023

Study Start

January 15, 2023

Primary Completion

September 15, 2023

Study Completion

September 15, 2023

Last Updated

July 5, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

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.

Locations