Clinical trial NCT04576585: Appetite Lexicon Training
Official title: Appetite Lexicon Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appetitive Behavior
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2020-10-06
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: specificity of responses
timeFrame: start of study, day 1
measure: specificity of responses
timeFrame: study completion, 9 weeks
measure: test reliability
timeFrame: start of study, day 1
measure: test reliability
timeFrame: study completion, 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue Univeristy
state: Indiana
Study officials:
affiliation: Purdue University
name: Richard D Mattes, PhD
role: PRINCIPAL_INVESTIGATOR
References: