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OpenTrials
Completed

NCT Number: NCT04576585

Appetite Lexicon Training

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Purdue Univeristy

West Lafayette, Indiana, 47907, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lexicon training

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. test reliability

    Time frame: start of study, day 1

    measure if training in appetite descriptors will result in higher reliability in the appetite questionnaire.

  4. test reliability

    Time frame: study completion, 9 weeks

    measure if training in appetite descriptors will result in higher reliability in the appetite questionnaire.

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 6, 2020
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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