Testing the Abuse Liability of Hyper-palatable Foods
11 septembre 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
168
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Tera Fazzino, Doctorate
- Numéro de téléphone: 785-864-0062
- E-mail: tfazzino@ku.edu
Sauvegarde des contacts de l'étude
- Nom: Cash Petree, B.S.
- Numéro de téléphone: 615-999-5677
- E-mail: cashpetree@ku.edu
Lieux d'étude
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Kansas
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Lawrence, Kansas, États-Unis, 66049
- Recrutement
- Dole Human Development Center
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Contact:
- Tera Fazzino, Doctorate
- Numéro de téléphone: 785-864-0062
- E-mail: tfazzino@ku.edu
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La 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)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: 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.
|
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.
|
|
Autre: 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.
|
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.
|
|
Autre: 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.
|
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.
|
|
Autre: 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.
|
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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Subjective effect measure: food stimulus liking
Délai: Baseline, at each visit
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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
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Baseline, at each visit
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Subjective effect measure: food stimulus wanting/desire
Délai: Baseline, at each visit
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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.
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Baseline, at each visit
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Subjective effect measure: food stimulus craving
Délai: Baseline, at each visit
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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.
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Baseline, at each visit
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Subjective effect measure: food stimulus likelihood to use again
Délai: Baseline, at each visit
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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.
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Baseline, at each visit
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Demand elasticity value of the food stimulus
Délai: Baseline, at each visit
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Primary outcome of the Food Purchase Task, which characterizes sensitivity to the cost of a food stimulus with escalations in price.
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Baseline, at each visit
|
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Breakpoint value in self-administration task
Délai: Baseline, at each visit
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Highest schedule completed to earn a food stimulus reward during the self-administration task
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Baseline, at each visit
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Subjective effect measure: food stimulus flavor intensity
Délai: 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.
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Baseline, at each visit
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Subjective effect measure: food stimulus relaxation
Délai: 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.
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Baseline, at each visit
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
8 septembre 2026
Achèvement primaire (Estimé)
1 novembre 2030
Achèvement de l'étude (Estimé)
30 janvier 2031
Dates d'inscription aux études
Première soumission
22 juillet 2026
Première soumission répondant aux critères de contrôle qualité
17 août 2026
Première publication (Réel)
20 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
14 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 septembre 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- STUDY00151790
- 1R01DA062585-01A1 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
Participant-level data will be shared with National Addiction & Health Data Archive Program (NAHDAP).
Délai de partage IPD
When the main outcomes are published (anticipated 2031)
Critères d'accès au partage IPD
Study data will be housed at NIH's National Data Archive.
Other study details will be posted on the study's clinicaltrials.gov
site.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- ANALYTIC_CODE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .