Testing the Abuse Liability of Hyper-palatable Foods

August 17, 2026 updated by: University of Kansas

Bet You Can't Eat Just One: Testing the Abuse Liability of Hyper-palatable Foods

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Tera Fazzino, Doctorate
  • Phone Number: 785-864-0062
  • Email: tfazzino@ku.edu

Study Contact Backup

Study Locations

  • United States
    • Kansas
      • Lawrence, Kansas, United States, 66049
        • Dole Human Development Center
        • Contact:
          • Tera Fazzino, Doctorate
          • Phone Number: 785-864-0062
          • Email: tfazzino@ku.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Sequence 1: Full Dose HPF → Modified Dose- No Fat → Modified Dose No Sodium → Negative Control
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

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.

Other: Modified 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.
Other: Modified 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
Other: Jicama 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.
Other: Sequence 2: Modified Dose- No Fat → Modified Dose- No Sodium → Negative Control → Full Dose HPF
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

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.

Other: Modified 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.
Other: Modified 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
Other: Jicama 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.
Other: Sequence 3: Modified Dose- No Sodium → Negative Control → Full Dose HPF → Modified Dose- No Fat
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

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.

Other: Modified 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.
Other: Modified 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
Other: Jicama 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.
Other: Sequence 4: Negative Control → Full Dose HPF → Modified Dose- No Fat → Modified Dose- No Sodium
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

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.

Other: Modified 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.
Other: Modified 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
Other: Jicama 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective effect measure: food stimulus liking
Time Frame: 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
Baseline, at each visit
Subjective effect measure: food stimulus wanting/desire
Time Frame: 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.
Baseline, at each visit
Subjective effect measure: food stimulus craving
Time Frame: 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.
Baseline, at each visit
Subjective effect measure: food stimulus likelihood to use again
Time Frame: 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.
Baseline, at each visit
Demand elasticity value of the food stimulus
Time Frame: 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.
Baseline, at each visit
Breakpoint value in self-administration task
Time Frame: Baseline, at each visit
Highest schedule completed to earn a food stimulus reward during the self-administration task
Baseline, at each visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective effect measure: food stimulus flavor intensity
Time Frame: 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.
Baseline, at each visit
Subjective effect measure: food stimulus relaxation
Time Frame: 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.
Baseline, at each visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas

Collaborators

National Institute on Drug Abuse (NIDA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

November 1, 2030

Study Completion (Estimated)

January 30, 2031

Study Registration Dates

First Submitted

July 22, 2026

First Submitted That Met QC Criteria

August 17, 2026

First Posted (Actual)

August 20, 2026

Study Record Updates

Last Update Posted (Actual)

August 20, 2026

Last Update Submitted That Met QC Criteria

August 17, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY00151790
  • 1R01DA062585-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Participant-level data will be shared with National Addiction & Health Data Archive Program (NAHDAP).

IPD Sharing Time Frame

When the main outcomes are published (anticipated 2031)

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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