Appetitive BehaviorNCT04576585
Appetite Lexicon Training
A study testing Lexicon training in people with Appetitive Behavior, run by Purdue University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetitive Behavior
- What is being tested?
- Lexicon training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2020to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
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. 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.
Read the 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.
- Conditions
- Appetitive Behavior
- Being tested
- Lexicon training
- Medical subject headings
- Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lexicon trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Appetite lexicon training group | Experimental | They will get appetite lexicon training in week three. Receives: Behavioral: Lexicon training |
| taste Lexicon training | Active comparator | They will get taste lexicon training In week three. Receives: Behavioral: Lexicon training |
What is being measured
The primary outcome is the main question the study is designed to answer.
specificity of responses
to measure if training in appetite descriptors leads to more specific responses in the appetite questionnaire.
Measured: start of study, day 1
specificity of responses
to measure if training in appetite descriptors leads to more specific responses in the appetite questionnaire.
Measured: study completion, 9 weeks
test reliability
measure if training in appetite descriptors will result in higher reliability in the appetite questionnaire.
Measured: start of study, day 1
test reliability
measure if training in appetite descriptors will result in higher reliability in the appetite questionnaire.
Measured: study completion, 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start25 Aug 2020
- Primary completion30 Aug 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appetitive BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Mattes, Purdue University
- Investigators
- Richard D Mattes, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576585
- Sponsor's protocol ID
- 2020-214
- Status last verified
- May 2024
- First submitted
- 10 Sep 2020
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appetite Lexicon Training
- ClinicalTrials.gov ID
- NCT04576585
- Acronym / sponsor ID
- 2020-214
- Conditions
- Appetitive Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 6 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Appetite lexicon training group | Experimental | Behavioral: Lexicon trainingThey will get appetite lexicon training in week three. |
| taste Lexicon training | Active comparator | Behavioral: Lexicon trainingThey will get taste lexicon training In week three. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.))
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lexicon trainingParticipants 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. | Behavioural | Appetite lexicon training group, taste Lexicon training |
Primary outcome
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.
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.
test reliability
Time frame: start of study, day 1
measure if training in appetite descriptors will result in higher reliability in the appetite questionnaire.
test reliability
Time frame: study completion, 9 weeks
measure if training in appetite descriptors will result in higher reliability in the appetite questionnaire.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard D Mattes, PhD principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lexicon training in people with Appetitive Behavior, run by Purdue University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
specificity of responses (time frame: start of study, day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.