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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04576585
Other study ID # 2020-214
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 25, 2020
Est. completion date December 30, 2022

Study information

Verified date May 2024
Source Purdue University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date December 30, 2022
Est. primary completion date August 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: 1. BMI 18-25 kg/m2. 2. Age 18-60 years. 3. Body weight fluctuation of <2.5kg in the past 3 months. 4. Fasting blood glucose below 6.1mmol/1 via capillary finger-stick blood sample using a SureStep glucometer (Lifescan, Milpitas, CA). 5. Regular eating pattern (i.e., reliable timing of eating events (±1 hour at least 5 days/wk - absolute pattern is less important than consistency.)) 6. Willing to eat all test foods. Exclusion Exclusion Criteria: 1. Having an acute disease. 2. Planning to initiate or terminate the use of medication known to affect appetite. 3. Diagnosed relevant chronic health conditions (e.g. diabetes, cardiovascular disease). 4. Allergies to eggs, peanuts, gluten, dairy, and carrots. 5. Age 61+ years

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Lexicon training
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.

Locations

Country Name City State
United States Purdue Univeristy West Lafayette Indiana

Sponsors (1)

Lead Sponsor Collaborator
Purdue University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary specificity of responses to measure if training in appetite descriptors leads to more specific responses in the appetite questionnaire. start of study, day 1
Primary specificity of responses to measure if training in appetite descriptors leads to more specific responses in the appetite questionnaire. study completion, 9 weeks
Primary test reliability measure if training in appetite descriptors will result in higher reliability in the appetite questionnaire. start of study, day 1
Primary test reliability measure if training in appetite descriptors will result in higher reliability in the appetite questionnaire. study completion, 9 weeks
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