Energy Metabolism and Eating Behavior in Underweight and Normal-weight Individuals (PROB I)
22 juin 2026 mis à jour par: Jose Galgani
Metabolic Flexibility, Eating Behavior and Adipose Tissue Expandability: Role of This Triad in the Propensity to Human Obesity
This study evaluates eating behavior and metabolic responses following consumption of a high-fat high-energy meal in healthy underweight and normal-weight adults.
The primary research question is: Do healthy underweight individuals exhibit different eating and metabolic responses compared with normal-weight adults following consumption of a high-fat high-energy meal?
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
Healthy underweight individuals have a body mass index below the normal range in the absence of a medical condition, food aversion, food insecurity, or evidence of unusually high levels of physical activity. Although the environmental factors contributing to their lower body mass index are not fully understood, these individuals may represent a phenotype resistant to the obesogenic environment. If so, the biological mechanisms underlying this resistance remain poorly understood. Such mechanisms must ultimately influence energy expenditure, energy intake, or both.
This study will compare metabolic responses and eating behavior during fasting and following consumption of a high-fat, high-energy meal in healthy underweight and normal-weight adults. Eating behavior will be assessed through measures of food liking, subjective appetite perceptions, and ad libitum energy intake. Metabolic responses will include assessments of energy expenditure, substrate oxidation, and circulating metabolites and hormones.
We hypothesize that healthy underweight individuals will exhibit greater postprandial satiety and lower ad libitum energy intake than normal-weight adults.
Type d'étude
Interventionnel
Inscription (Réel)
59
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
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Santiago Metropolitan
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Santiago, Santiago Metropolitan, Chili
- Avda. Libertador Bernardo O´Higgins 340
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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
Non
La description
Inclusion criteria:
- Men or women
- Age 18-25 years
- Stable body weight during the previous 6 months (±2 kg)
- Healthy according to medical history and laboratory assessments
- BMI: 15.0-<18.5 kg/m2 or 20.0-<25.0 kg/m2
Exclusion criteria:
- Pregnancy or lactation
- Athletes or individuals engaged in high levels of physical activity, including those participating in competitive sports, structured endurance training, or physically demanding occupations.
- Cardiovascular, liver, kidney, thyroid, or other chronic diseases requiring medical treatment
- Conditions affecting energy metabolism or eating behavior
- Smoking or alcohol abuse
- Phobia or vasovagal response associated with blood draws
- Intolerance or allergy to peanuts, chocolate, eggs, or gluten
- Irregular menstrual cycles (>3 months without menstruation)
- Current or previous diagnosis of eating disorders
- Psychiatric disorders requiring antidepressant or psychotropic treatment
Additional criterion for healthy underweight participants:
- Absence of food insecurity
- Low body weight not attributable to eating disorders or exercise-related behaviors
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: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: High-fat, high-energy meal
Healthy underweight and normal-weight adults will consume a standardized high-fat, high-energy meal following an overnight fast.
Assessments will include appetite sensations, energy expenditure, circulating biomarkers, and ad libitum food intake.
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Following an overnight fast, participants will consume a standardized high-fat high-energy meal under controlled laboratory conditions.
During the subsequent postprandial period, appetite sensations, energy expenditure, circulating biomarkers, and food intake will be assessed.
Food intake will be evaluated using an ad libitum meal test consisting of two sequential phases involving foods with different sensory and nutritional characteristics.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Total ad-libitum energy intake
Délai: The feeding test will be conducted 6.5 hours after the high-fat, high-energy meal.
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Total energy intake consumed during the ad libitum feeding test.
Participants will be provided with a selection of foods and instructed to eat ad libitum until comfortably satiated.
The weight of each food item will be recorded before and after consumption, and intake will be determined from the difference.
Total energy intake (kcal) will be calculated from the nutrient composition of the foods consumed using standard energy conversion factors.
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The feeding test will be conducted 6.5 hours after the high-fat, high-energy meal.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Food liking
Délai: Measured during the screening visit.
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Food liking will be assessed in the fasted state using a computerized questionnaire comprising 67 foods commonly available in retail food stores.
The food list includes a wide variety of items differing in energy density, macronutrient composition, degree of processing, and sensory characteristics, including fruits, vegetables, legumes, grains, dairy products, meats, nuts, snack foods, and desserts.
Images of the foods will be presented individually on a computer screen, and participants will rate their liking of each item using a 9-point Likert scale ranging from 1 ("dislike extremely") to 9 ("like extremely").
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Measured during the screening visit.
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Body composition
Délai: Measured during a dedicated body composition assessment visit.
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Whole-body and regional body composition assessed by dual-energy X-ray absorptiometry (DXA).
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Measured during a dedicated body composition assessment visit.
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Subjective appetite sensations
Délai: Repeatedly measured during the metabolic test before and following consumption of the high-fat, high-energy meal.
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Appetite sensations will be assessed at fasting and during the postprandial period using 100-mm visual analogue scales.
Participants will rate hunger, fullness, desire to eat, and prospective food consumption.
Scores will be quantified as the distance (mm) from the left anchor, with higher scores indicating greater intensity of the rated sensation.
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Repeatedly measured during the metabolic test before and following consumption of the high-fat, high-energy meal.
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Energy expenditure and fuel oxidation
Délai: Repeatedly measured during the metabolic test before and following consumption of the high-fat, high-energy meal.
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Energy expenditure and fuel oxidation will be assessed in the fasted state and during the postprandial period using indirect calorimetry.
Oxygen consumption and carbon dioxide production will be measured under standardized conditions using a ventilated hood system.
Energy expenditure will be calculated from respiratory gas exchange data using standard equations.
Rates of carbohydrate and fat oxidation will be estimated from respiratory gas exchange measurements, with adjustments for urinary nitrogen excretion using standard stoichiometric equations.
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Repeatedly measured during the metabolic test before and following consumption of the high-fat, high-energy meal.
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Circulating metabolite and hormonal concentrations
Délai: Repeatedly measured during the metabolic test before and following consumption of the high-fat, high-energy meal.
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Blood samples obtained in the fasted state and throughout the postprandial period will be analyzed for concentrations of glucose, free fatty acids, β-hydroxybutyrate, triglycerides, and insulin.
Concentrations will be determined using validated clinical chemistry and immunoassay methods.
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Repeatedly measured during the metabolic test before and following consumption of the high-fat, high-energy meal.
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Collaborateurs et enquêteurs
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Collaborateurs
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)
23 mars 2023
Achèvement primaire (Réel)
16 janvier 2026
Achèvement de l'étude (Réel)
16 janvier 2026
Dates d'inscription aux études
Première soumission
22 juin 2026
Première soumission répondant aux critères de contrôle qualité
22 juin 2026
Première publication (Réel)
26 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
26 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
22 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 210624007
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
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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