Ultra-Processed Foods, Palatability, Appetite, and Gastrointestinal Transit
20 mai 2026 mis à jour par: Richard Mattes, Purdue University
Ultra-Processed Foods - Palatability and Appetite
The goal of this clinical trial is to learn how food processing level affects appetite and gastrointestinal transit time when meal palatability is changed.
Participants will complete one screening visit and four test visits.
During each test visit, participants will consume one of four meals that differ by food processing level and palatability: high-palatability ultra-processed food, low-palatability ultra-processed food, high-palatability non-ultra-processed food, or low-palatability non-ultra-processed food.
The main questions this study aims to answer are whether food processing and palatability affect appetite sensations and gastrointestinal transit time.
Participants will rate appetite sensations during each test visit and provide breath samples to measure gastrointestinal transit time.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
This is a randomized crossover trial examining the effects of food processing level and palatability on appetite and gastrointestinal transit time.
Participants will complete a screening visit followed by four test visits, with each test visit separated by at least one week.
Each participant will consume all four test meals: high-palatability ultra-processed food, low-palatability ultra-processed food, high-palatability non-ultra-processed food, and low-palatability non-ultra-processed food.
Palatability will be reduced by adding bitter melon powder to the low-palatability meals.
During each test visit, participants will consume the assigned test meal containing lactulose as a marker of gastrointestinal transit time.
Breath samples will be collected to assess orocecal transit time using hydrogen analysis.
Participants will also rate meal palatability and appetite sensations, including hunger, fullness, desire to eat, amount they could eat, and thirst, using visual analog scales during the test visit.
Type d'étude
Interventionnel
Inscription (Réel)
40
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.
Lieux d'étude
-
-
Indiana
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West Lafayette, Indiana, États-Unis, 47907
- Purdue University
-
-
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
Accepte les volontaires sains
Oui
La description
Inclusion Criteria:
- Individuals aged 18 to 60 years.
- Any sex, gender, or orientation.
- Self-reported good health.
- No medication use.
- No allergies or food sensitivities to any of the foods used in the study.
- No anticipated change in physical activity during the study period.
- Willingness to complete all planned study activities, including the screening visit and four test visits.
- At screening, participants must rate the selected high-palatability foods between 60 and 90 on a 100-unit visual analog scale, where 100 = extremely palatable.
- At screening, participants must rate the selected low-palatability foods between 10 and 40 on a 100-unit visual analog scale.
Exclusion Criteria:
- Younger than 18 years or older than 60 years.
- Current medication use.
- Allergies or food sensitivities to any study foods.
- Not meeting the required palatability rating ranges during screening.
- Anticipated change in physical activity during the study period.
- Not self-reporting good health.
- Unwillingness or inability to complete the planned study activities.
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: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Palatable Ultra-Processed Food
Participants will consume a palatable ultra-processed test meal during one study visit.
The meal will be used to assess appetite sensations, palatability ratings, and gastrointestinal transit time.
|
Participants will consume a palatable ultra-processed test meal during one study visit.
The meal will consist of commonly available ultra-processed food items and will be used to assess appetite sensations, meal palatability, and gastrointestinal transit time.
|
|
Expérimental: Unpalatable Ultra-Processed Food
Participants will consume an unpalatable ultra-processed test meal during one study visit.
Palatability will be reduced by adding bitter melon powder.
The meal will be used to assess appetite sensations, palatability ratings, and gastrointestinal transit time.
|
Participants will consume an unpalatable ultra-processed test meal during one study visit.
Palatability will be reduced by adding organic bitter melon powder to the ultra-processed meal.
The meal will be used to assess appetite sensations, meal palatability, and gastrointestinal transit time.
|
|
Expérimental: Palatable Non-Ultra-Processed Food
Participants will consume a palatable non-ultra-processed test meal during one study visit.
The meal will be used to assess appetite sensations, palatability ratings, and gastrointestinal transit time.
|
Participants will consume a palatable non-ultra-processed test meal during one study visit.
The meal will consist of commonly available non-ultra-processed food items and will be used to assess appetite sensations, meal palatability, and gastrointestinal transit time.
|
|
Expérimental: Unpalatable Non-Ultra-Processed Food
Participants will consume a unpalatable non-ultra-processed test meal during one study visit.
Palatability will be reduced by adding bitter melon powder.
The meal will be used to assess appetite sensations, palatability ratings, and gastrointestinal transit time.
|
Participants will consume an unpalatable non-ultra-processed test meal during one study visit.
Palatability will be reduced by adding organic bitter melon powder to the non-ultra-processed meal.
The meal will be used to assess appetite sensations, meal palatability, and gastrointestinal transit time.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Orocecal Transit Time
Délai: During each test visit, up to 4.5 hours after meal consumption
|
Orocecal transit time will be assessed using hydrogen analysis of end-alveolar breath samples collected after consumption of each test meal.
Each test meal will contain lactulose as a marker of gastrointestinal transit time.
|
During each test visit, up to 4.5 hours after meal consumption
|
|
Appetite Sensations
Délai: During each test visit, up to 4.5 hours after meal consumption
|
Appetite sensations, including hunger, fullness, desire to eat, prospective food consumption, and thirst, will be assessed using 100-mm visual analog scales during each test visit after consumption of the assigned test meal every 30 minutes.
Each visual analog scale ranges from 0 to 100 mm, with higher scores indicating a greater intensity of the rated sensation.
Higher scores are not inherently better or worse outcomes, but reflect greater hunger, fullness, desire to eat, prospective food consumption, or thirst, depending on the item.
|
During each test visit, up to 4.5 hours after meal consumption
|
|
Meal Palatability Ratings
Délai: During each test visit, up to 4.5 hours after meal consumption
|
Meal palatability will be assessed using a 100-mm general labeled magnitude scale during each study visit.
The scale ranges from 0 to 100 mm, with 0 mm anchored by "most disliked sensation imaginable," 50 mm anchored by "neutral," and 100 mm anchored by "most liked sensation imaginable."
Higher scores indicate greater liking of the test meal and therefore a more favorable palatability rating.
|
During each test visit, up to 4.5 hours after meal consumption
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
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)
24 septembre 2024
Achèvement primaire (Réel)
30 avril 2026
Achèvement de l'étude (Réel)
30 avril 2026
Dates d'inscription aux études
Première soumission
14 mai 2026
Première soumission répondant aux critères de contrôle qualité
14 mai 2026
Première publication (Réel)
20 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
22 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
20 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB-2024-450
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
Individual participant data will not be shared because the current IRB-approved protocol does not include a formal plan for external individual participant data sharing.
Study data will be de-identified for analysis, and identifying information will be stored separately from study data.
Code numbers linking participants to their data will be destroyed according to the approved protocol.
No information by which participants can be identified will be released or published.
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
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