- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07671105
Energy Metabolism and Eating Behavior in Underweight and Normal-weight Individuals (PROB I)
Metabolic Flexibility, Eating Behavior and Adipose Tissue Expandability: Role of This Triad in the Propensity to Human Obesity
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Santiago Metropolitan
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Santiago, Santiago Metropolitan, Chile
- Avda. Libertador Bernardo O´Higgins 340
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total ad-libitum energy intake
Time Frame: 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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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Food liking
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 210624007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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