Abuse Liability, Hyperpalatable Foods
Conditions
Keywords
hyperpalatable foods, abuse liability, laboratory
Brief summary
The study will conduct a laboratory study designed to evaluate the rewarding and addictive properties of hyper-palatable foods (HPF), using potato chips as the food stimulus/sample HPF.
Detailed description
A within-subjects, double-blind, randomized crossover design will be used to test the abuse liability of a commonly consumed hyper-palatable food (HPF; potato chips) in controlled laboratory conditions, compared to a negative (non-HPF) control and modified doses (Aim 1). In alignment with FDA requirements, the study will randomize participants to complete four study sessions in one of four mixed orders to counterbalance the ordering of food stimuli across participants. One food will be assessed per session. Abuse liability tests will consist of an acute dose effects comparison to evaluate differences in acute rewarding effects, and a test of HPF reinforcing effects via a self-administration task and behavioral economic food purchase task. Participants will be community members who report high dietary intake of potato chips (HPF stimulus in the study), and do not have substance use disorder or eating disorders, which may present confounds.
Interventions
OTHERFull Dose HPF
This food stimulus is a regular, fried potato chip (with no modifications), considered the full dose hyper-palatable food stimulus. The nutrient characteristics are as followed (per 7 grams): 40kcal calories, 2.5g fat, 35mg sodium, 3.8g carbs.
OTHERModified Dose- No Fat
The food stimulus is a baked/"air fried" potato chip with sodium. Thus, the stimulus will have almost no fat. The nutrient characteristics are as followed (per 7 grams): 34kcal calories, 0.9g fat, 37mg sodium, 4.0g carbs.
OTHERModified Dose- No Sodium
The food stimulus will be a fried potato chip, unsalted. The nutrient characteristics are as followed (per 7 grams): 38kcal calories, 2.5g fat, 0.6mg sodium, 3.8g carbs
OTHERJicama Root Vegetable Chip- Negative Control
The food stimulus is a baked/"air fried" Jicama root vegetable chip which will serve as the negative control with no sodium, fat, and lower carbohydrates. The nutrient characteristics are as followed (per 7 grams): 20kcal calories, 0g fat, 0.1g sodium, 0.7g carbs.
Sponsors
University of Kansas
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
All food items will be prepared to ensure that all products appear visually the same, to retain blinding of all stimuli. We will use a baking process that ensures that baked chip stimuli (mod NF and negative control) have the same visual and texture properties as the full potato chips and mod-NS chips, which will be fried. The baked stimuli will be baked in a convection oven at high heat, a process known as "air frying." The baked products will be lightly brushed with oil, which yields an outer coating that visually resembles fried potato chips, and makes them crunchy with the same consistency as regular chips. Our pilot study demonstrated effective blinding of the food stimuli to participants.
Intervention model description
The study will be a randomized crossover design in which participants will be assigned to complete study sessions in a randomized order. All participants will complete all sessions and encounter all study food conditions/stimuli.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults 18+ years old * High dietary intake of regular potato chips (HPF stimulus in the study), identified as \>=3 times per week via a standard dietary history questionnaire * Like potato chips, the study-provided food (rating of \>6 out of 10 on visual analogue scale) and willing to consume them in the lab.
Exclusion criteria
* Currently prescribed medications for weight loss (e.g., Ozempic), attention deficit hyperactivity disorder, substance use disorder, or binge eating disorder * Substance use disorder diagnosis in the past year (self-reported) or substantial consequences from substance use in the past year (score on Drug Abuse Screening Test-10 of 6 or higher) * Eating disorder diagnosis in the past year * Bariatric surgery in the past year * Dietary allergies or restrictions to gluten * Dietary allergies or restrictions to root vegetables * Currently participating in a weight management treatment program or engaging in dietary modification to induce weight loss * Trying to cut down on HPF intake * Diagnosed smell or taste dysfunction * Currently pregnant * Diagnosed cognitive impairment (self-reported)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective effect measure: food stimulus liking | Baseline, at each visit | During the acute dose effects comparison, participants will rate on a visual analogue scale (0-100) how much they like the food stimulus they tasted |
| Subjective effect measure: food stimulus wanting/desire | Baseline, at each visit | During the acute dose effects comparison, participants will rate on a visual analogue scale (0-100) how much they desire more of the food stimulus they tasted. |
| Subjective effect measure: food stimulus craving | Baseline, at each visit | During the acute dose effects comparison, participants will rate on a visual analogue scale (0-100) how much they crave the food stimulus they tasted. |
| Subjective effect measure: food stimulus likelihood to use again | Baseline, at each visit | During the acute dose effects comparison, participants will rate on a visual analogue scale (0-100) how likely they would be to use the food stimulus they tasted again in the future. |
| Demand elasticity value of the food stimulus | Baseline, at each visit | Primary outcome of the Food Purchase Task, which characterizes sensitivity to the cost of a food stimulus with escalations in price. |
| Breakpoint value in self-administration task | Baseline, at each visit | Highest schedule completed to earn a food stimulus reward during the self-administration task |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective effect measure: food stimulus flavor intensity | Baseline, at each visit | During the acute dose effects comparison, participants will rate on a visual analogue scale (0-100) how intense the flavor of the food stimulus is that they tasted. |
| Subjective effect measure: food stimulus relaxation | Baseline, at each visit | During the acute dose effects comparison, participants will rate on a visual analogue scale (0-100) how relaxed they felt from the food stimulus they tasted. |
Countries
United States
Contacts
CONTACTTera Fazzino, Doctorate
CONTACTCash Petree, B.S.
Outcome results
None listed