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Hyperpalatable FoodsNCT07776938

Testing the Abuse Liability of Hyper-palatable Foods

A study testing Full Dose HPF, Modified Dose- No Fat and Modified Dose- No Sodium in people with Hyperpalatable Foods and Abuse Liability, run by University of Kansas at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Hyperpalatable Foods, Abuse Liability
What is being tested?
Full Dose HPF, Modified Dose- No Fat and Modified Dose- No Sodium
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
1 siteUnited States
Study dates
8 Sep 2026to 30 Jan 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tera Fazzino, Doctorate contact

785-864-0062

tfazzino@ku.edu

Cash Petree, B.S. contact

615-999-5677

cashpetree@ku.edu

United States1 site, 1 recruiting
  • Dole Human Development Center

    Lawrence, Kansas, 66049

    Tera Fazzino, Doctorate, 785-864-0062, tfazzino@ku.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Full Dose HPF, Modified Dose- No Fat, Modified Dose- No Sodium, Jicama Root Vegetable Chip- Negative Control
Keywords
hyperpalatable foods, abuse liability, laboratory

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Full Dose HPFOther

    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.

  • Modified Dose- No FatOther

    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.

  • Modified Dose- No SodiumOther

    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

  • Jicama Root Vegetable Chip- Negative ControlOther

    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.

Study groups in NCT07776938
Study groupRoleWhat they receive
Sequence 1: Full Dose HPF → Modified Dose- No Fat → Modified Dose No Sodium → Negative ControlOtherParticipants 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.
Receives: Other: Full Dose HPF; Other: Modified Dose- No Fat; Other: Modified Dose- No Sodium; Other: Jicama Root Vegetable Chip- Negative Control
Sequence 2: Modified Dose- No Fat → Modified Dose- No Sodium → Negative Control → Full Dose HPFOtherParticipants 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.
Receives: Other: Full Dose HPF; Other: Modified Dose- No Fat; Other: Modified Dose- No Sodium; Other: Jicama Root Vegetable Chip- Negative Control
Sequence 3: Modified Dose- No Sodium → Negative Control → Full Dose HPF → Modified Dose- No FatOtherParticipants 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.
Receives: Other: Full Dose HPF; Other: Modified Dose- No Fat; Other: Modified Dose- No Sodium; Other: Jicama Root Vegetable Chip- Negative Control
Sequence 4: Negative Control → Full Dose HPF → Modified Dose- No Fat → Modified Dose- No SodiumOtherParticipants 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.
Receives: Other: Full Dose HPF; Other: Modified Dose- No Fat; Other: Modified Dose- No Sodium; Other: Jicama Root Vegetable Chip- Negative Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline, at each visit

  2. 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.

    Measured: Baseline, at each visit

  3. 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.

    Measured: Baseline, at each visit

  4. 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.

    Measured: Baseline, at each visit

  5. 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.

    Measured: Baseline, at each visit

  6. Breakpoint value in self-administration task

    Highest schedule completed to earn a food stimulus reward during the self-administration task

    Measured: Baseline, at each visit

Secondary outcomes (2)
  1. 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.

    Measured: Baseline, at each visit

  2. 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.

    Measured: Baseline, at each visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2026
  2. Study start8 Sep 2026
  3. Primary completionNov 2030 (estimated)
  4. Study completion30 Jan 2031 (estimated)

Resources

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
Crossover
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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
168 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07776938
Sponsor's protocol ID
STUDY00151790
Other IDs
1R01DA062585-01A1
Status last verified
Jul 2026
First submitted
22 Jul 2026
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Participant-level data will be shared with National Addiction \& Health Data Archive Program (NAHDAP).

Publications

  • Fazzino TL, Stratton MS, Lange M, Gearhardt AN, Tidey JW. Regulatory science methods can test the addictive properties of foods: A proof-of-concept pilot study. Exp Clin Psychopharmacol. 2026 Jun;34(3):295-304. doi: 10.1037/pha0000818. Epub 2026 Apr 30.

    PubMed 42060408

Questions about this trial

What is this clinical trial studying?

A study testing Full Dose HPF, Modified Dose- No Fat and Modified Dose- No Sodium in people with Hyperpalatable Foods and Abuse Liability, run by University of Kansas 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 3 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 14 Sep 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tera Fazzino, Doctorate (785-864-0062, tfazzino@ku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjective effect measure: food stimulus liking (time frame: Baseline, at each visit). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07776938, which also lists 1 linked publication.

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 14 Sep 2026.

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