An interventional study of Full Dose HPF and Modified Dose- No Fat in Hyperpalatable Foods and Abuse Liability, sponsored by University of Kansas. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by University of Kansas · Not applicable, Interventional, and Basic science
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.
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.
University of Kansas is the lead sponsor of 81 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Participants receive Full Dose HPF chip at Visit 1, Modified Dose- No Fat chip at Visit 2, Modified Dose- No Sodium chip at Visit 3, and Negative Control chip at Visit 4.
Other: Full Dose HPF · Other: Modified Dose- No Fat · Other: Modified Dose- No Sodium · Other: Jicama Root Vegetable Chip- Negative Control
Participants receive Modified Dose- No Fat chip at Visit 1, Modified Dose- No Sodium chip at Visit 2, Negative Control chip at Visit 3, and Full Dose HPF chip at Visit 4.
Other: Full Dose HPF · Other: Modified Dose- No Fat · Other: Modified Dose- No Sodium · Other: Jicama Root Vegetable Chip- Negative Control
Participants receive Modified No Salt chip at Visit 1, Negative Control chip at Visit 2, Full Dose HPF chip at Visit 3, and Modified No Fat chip at Visit 4.
Other: Full Dose HPF · Other: Modified Dose- No Fat · Other: Modified Dose- No Sodium · Other: Jicama Root Vegetable Chip- Negative Control
Participants receive Negative Control chip at Visit 1, Full Dose HPF chip at Visit 2, Modified No Fat chip at Visit 3, and Modified No Salt chip at Visit 4.
Other: Full Dose HPF · Other: Modified Dose- No Fat · Other: Modified Dose- No Sodium · Other: Jicama Root Vegetable Chip- Negative Control
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.
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.
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
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.
Subjective effect measure: food stimulus liking
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
Time frame: Baseline, at each visit
Subjective effect measure: food stimulus wanting/desire
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.
Time frame: Baseline, at each visit
Subjective effect measure: food stimulus craving
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.
Time frame: Baseline, at each visit
Subjective effect measure: food stimulus likelihood to use again
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.
Time frame: Baseline, at each visit
Demand elasticity value of the food stimulus
Primary outcome of the Food Purchase Task, which characterizes sensitivity to the cost of a food stimulus with escalations in price.
Time frame: Baseline, at each visit
Breakpoint value in self-administration task
Highest schedule completed to earn a food stimulus reward during the self-administration task
Time frame: Baseline, at each visit
Subjective effect measure: food stimulus flavor intensity
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.
Time frame: Baseline, at each visit
Subjective effect measure: food stimulus relaxation
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.
Time frame: Baseline, at each visit
Plan to share: Yes — Participant-level data will be shared with National Addiction \& Health Data Archive Program (NAHDAP).
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: When the main outcomes are published (anticipated 2031)
Access criteria: Study data will be housed at NIH's National Data Archive. Other study details will be posted on the study's clinicaltrials.gov site.
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