- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04576585
Appetite Lexicon Training
March 28, 2023 updated by: Richard Mattes, Purdue University
A fundamental limitation to the application of appetitive sensations is how they are measured.
The most common approach relies on untrained individuals to self-report the sensations they experience under a given set of conditions.
Investigators believe this is problematic because assumptions made about participant ratings are likely not valid.
The proposed protocol will permit examination of whether training on appetite lexicon enhances the reliability of appetite ratings.
Investigators also hypothesize that different preloads will induce different magnitudes of appetite sensations (hunger, fullness, desire to eat, and prospective consumption) depending on their energy density.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A fundamental limitation to the application of appetitive sensations is how they are measured.
The most common approach relies on untrained individuals to self-report the sensations they experience under a given set of conditions.
Investigators believe this is problematic because assumptions made about participant ratings are likely not valid.
Most commonly, participants are asked to rate their hunger, desire to eat, fullness, and prospective consumption.
For example, researchers have demonstrated that hunger and fullness stem from different physiological processes (e.g., different gut-peptides and neurotransmitters) and serve different purposes (eating initiation (hunger), meal termination (fullness)) and, accordingly, expect participants to rate the two sensations independently.
However, participants treat them as opposite poles on a common continuum.
Additionally, in focus group analysis, consumers often use researcher-defined distinct terms interchangeably (hunger=desire to eat; fullness =lack of desire to eat).
However, the distinction between these sensations is clinically important.
Hunger and fullness do not always change reciprocally and equally in clinical conditions.
Hunger can change without a shift in fullness, and the reverse has also been reported.
Investigators believe reporting sensitivity, selectivity, and reliability can be improved by training participants on the terminology of appetitive sensations prior to testing, just as any bench researcher would calibrate their instruments before measurements.
The proposed protocol will permit examination of whether training on appetite lexicon enhances the reliability of appetite ratings.
Investigators also hypothesize that different preloads will induce different magnitudes of appetite sensations (hunger, fullness, desire to eat, and prospective consumption) depending on their energy density.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Eunjin Cheon
- Phone Number: 765-496-3607
- Email: cheone@purdue.edu
Study Contact Backup
- Name: Richard Mattes, PhD
- Phone Number: 765-494-0662
- Email: mattes@purdue.edu
Study Locations
-
-
Indiana
-
West Lafayette, Indiana, United States, 47907
- Purdue Univeristy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BMI 18-25 kg/m2.
- Age 18-60 years.
- Body weight fluctuation of <2.5kg in the past 3 months.
- Fasting blood glucose below 6.1mmol/1 via capillary finger-stick blood sample using a SureStep glucometer (Lifescan, Milpitas, CA).
- Regular eating pattern (i.e., reliable timing of eating events (±1 hour at least 5 days/wk - absolute pattern is less important than consistency.))
- Willing to eat all test foods. Exclusion
Exclusion Criteria:
- Having an acute disease.
- Planning to initiate or terminate the use of medication known to affect appetite.
- Diagnosed relevant chronic health conditions (e.g. diabetes, cardiovascular disease).
- Allergies to eggs, peanuts, gluten, dairy, and carrots.
- Age 61+ years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Appetite lexicon training group
They will get appetite lexicon training in week three.
|
Participants will receive training on the lexicon of appetite on up to 3 days during the training week.
This will entail reading written definitions, watching an instructional video, eating exercises and completing training exams demonstrating they understand the distinctions between appetitive terms (hunger, desire to eat, fullness, and prospective consumption).
The training will require about 30 minutes to complete.
To ensure the success of training, participants must verbally describe the definitions of the outcome sensations to a member of the research team and complete a written quiz with at least 90 % correct responses.
Failure to satisfactorily convey understanding of the concepts will result in an offer to repeat the training 2 more times or be rejected from the study.
|
Active Comparator: taste Lexicon training
They will get taste lexicon training In week three.
|
Participants will receive training on the lexicon of appetite on up to 3 days during the training week.
This will entail reading written definitions, watching an instructional video, eating exercises and completing training exams demonstrating they understand the distinctions between appetitive terms (hunger, desire to eat, fullness, and prospective consumption).
The training will require about 30 minutes to complete.
To ensure the success of training, participants must verbally describe the definitions of the outcome sensations to a member of the research team and complete a written quiz with at least 90 % correct responses.
Failure to satisfactorily convey understanding of the concepts will result in an offer to repeat the training 2 more times or be rejected from the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
specificity of responses
Time Frame: start of study, day 1
|
to measure if training in appetite descriptors leads to more specific responses in the appetite questionnaire.
|
start of study, day 1
|
specificity of responses
Time Frame: study completion, 9 weeks
|
to measure if training in appetite descriptors leads to more specific responses in the appetite questionnaire.
|
study completion, 9 weeks
|
test reliability
Time Frame: start of study, day 1
|
measure if training in appetite descriptors will result in higher reliability in the appetite questionnaire.
|
start of study, day 1
|
test reliability
Time Frame: study completion, 9 weeks
|
measure if training in appetite descriptors will result in higher reliability in the appetite questionnaire.
|
study completion, 9 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 25, 2020
Primary Completion (Actual)
August 30, 2022
Study Completion (Actual)
December 30, 2022
Study Registration Dates
First Submitted
September 10, 2020
First Submitted That Met QC Criteria
September 29, 2020
First Posted (Actual)
October 6, 2020
Study Record Updates
Last Update Posted (Actual)
March 29, 2023
Last Update Submitted That Met QC Criteria
March 28, 2023
Last Verified
April 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 2020-214
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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