NCT04576585

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 25, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2020

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 6, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

2 years

First QC Date

September 10, 2020

Last Update Submit

May 6, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • specificity of responses

    to measure if training in appetite descriptors leads to more specific responses in the appetite questionnaire.

    start of study, day 1

  • specificity of responses

    to measure if training in appetite descriptors leads to more specific responses in the appetite questionnaire.

    study completion, 9 weeks

  • test reliability

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

    start of study, day 1

  • test reliability

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

    study completion, 9 weeks

Study Arms (2)

Appetite lexicon training group

EXPERIMENTAL

They will get appetite lexicon training in week three.

Behavioral: Lexicon training

taste Lexicon training

ACTIVE COMPARATOR

They will get taste lexicon training In week three.

Behavioral: Lexicon training

Interventions

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.

Appetite lexicon training grouptaste Lexicon training

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.))

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue Univeristy

West Lafayette, Indiana, 47907, United States

Location

MeSH Terms

Conditions

Appetitive Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Richard D Mattes, PhD

    Purdue University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
randomly assigned
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Investigators will randomly assign recruited participants to one of two groups. One group will receive training in the lexicon of appetite (Hunger, Fullness, Desire to Eat, and Prospective Consumption), and the other group will be trained in the basic tastes (Sweetness, Sourness, Bitterness, and Saltiness) as an attention control. All participants will participate in two preload trials with mixed meals before training and six paired preload trials after training. Trials will be held once per week. On another day of the trial week, participants will record their appetite during the waking hours of one day through an online survey. The total duration of participation will be in 9 weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor

Study Record Dates

First Submitted

September 10, 2020

First Posted

October 6, 2020

Study Start

August 25, 2020

Primary Completion

August 30, 2022

Study Completion

December 30, 2022

Last Updated

May 7, 2024

Record last verified: 2024-05

Locations