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Energy Metabolism and Eating Behavior in Underweight and Normal-weight Individuals (PROB I)

22. Juni 2026 aktualisiert von: 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?

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

59

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Chile
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile
        • Avda. Libertador Bernardo O´Higgins 340

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Sonstiges: High-fat high-energy meal
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Total ad-libitum energy intake
Zeitfenster: The feeding test will be conducted 6.5 hours after the high-fat, high-energy meal.
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.
The feeding test will be conducted 6.5 hours after the high-fat, high-energy meal.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Food liking
Zeitfenster: Measured during the screening visit.
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").
Measured during the screening visit.
Body composition
Zeitfenster: Measured during a dedicated body composition assessment visit.
Whole-body and regional body composition assessed by dual-energy X-ray absorptiometry (DXA).
Measured during a dedicated body composition assessment visit.
Subjective appetite sensations
Zeitfenster: Repeatedly measured during the metabolic test before and following consumption of the high-fat, high-energy meal.
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.
Repeatedly measured during the metabolic test before and following consumption of the high-fat, high-energy meal.
Energy expenditure and fuel oxidation
Zeitfenster: Repeatedly measured during the metabolic test before and following consumption of the high-fat, high-energy meal.
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.
Repeatedly measured during the metabolic test before and following consumption of the high-fat, high-energy meal.
Circulating metabolite and hormonal concentrations
Zeitfenster: Repeatedly measured during the metabolic test before and following consumption of the high-fat, high-energy meal.
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.
Repeatedly measured during the metabolic test before and following consumption of the high-fat, high-energy meal.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Jose Galgani

Mitarbeiter

Agencia Nacional de Investigación y Desarrollo

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

23. März 2023

Primärer Abschluss (Tatsächlich)

16. Januar 2026

Studienabschluss (Tatsächlich)

16. Januar 2026

Studienanmeldedaten

Zuerst eingereicht

22. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

22. Juni 2026

Zuerst gepostet (Tatsächlich)

26. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

26. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

22. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 210624007

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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