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Testing the Abuse Liability of Hyper-palatable Foods

11 september 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

168

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

  • Namn: Tera Fazzino, Doctorate
  • Telefonnummer: 785-864-0062
  • E-post: tfazzino@ku.edu

Studera Kontakt Backup

Studieorter

  • Förenta staterna
    • Kansas
      • Lawrence, Kansas, Förenta staterna, 66049
        • Rekrytering
        • Dole Human Development Center
        • Kontakt:
          • Tera Fazzino, Doctorate
          • Telefonnummer: 785-864-0062
          • E-post: tfazzino@ku.edu

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Beskrivning

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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Grundläggande vetenskap
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: 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.
Övrig: 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.

Övrig: 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.
Övrig: 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
Övrig: 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.
Övrig: 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.
Övrig: 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.

Övrig: 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.
Övrig: 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
Övrig: 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.
Övrig: 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.
Övrig: 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.

Övrig: 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.
Övrig: 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
Övrig: 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.
Övrig: 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.
Övrig: 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.

Övrig: 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.
Övrig: 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
Övrig: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Subjective effect measure: food stimulus liking
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Baseline, at each visit
Highest schedule completed to earn a food stimulus reward during the self-administration task
Baseline, at each visit

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Subjective effect measure: food stimulus flavor intensity
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Kansas

Samarbetspartners

National Institute on Drug Abuse (NIDA)

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

8 september 2026

Primärt slutförande (Beräknad)

1 november 2030

Avslutad studie (Beräknad)

30 januari 2031

Studieregistreringsdatum

Först inskickad

22 juli 2026

Först inskickad som uppfyllde QC-kriterierna

17 augusti 2026

Första postat (Faktisk)

20 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

14 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 september 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • STUDY00151790
  • 1R01DA062585-01A1 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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

Tidsram för IPD-delning

When the main outcomes are published (anticipated 2031)

Kriterier för IPD Sharing Access

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-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ANALYTIC_CODE

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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