Healthy UnderweightPROB INCT07671105
Energy Metabolism and Eating Behavior in Underweight and Normal-weight Individuals
A study testing High-fat high-energy meal in people with Healthy Underweight and Normal Weight Adults, run by Jose Galgani at 1 site in Chile.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Healthy Underweight, Normal Weight Adults
- What is being tested?
- High-fat high-energy meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteChile
- Study dates
- 23 Mar 2023to 16 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Chile1 site
Avda. Libertador Bernardo O´Higgins 340
Santiago, Santiago Metropolitan
About this study
Official title: 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?
Read the 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.
- Conditions
- Healthy Underweight, Normal Weight Adults
- Being tested
- High-fat high-energy meal
- Keywords
- Healthy underweight, Energy metabolism, Energy intake, Food preferences, Eating behavior, High-fat feeding
- Medical subject headings
- Food Preferences, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-fat high-energy mealOther
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.
| Study group | Role | What they receive |
|---|---|---|
| High-fat, high-energy meal | Experimental | 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. Receives: Other: High-fat high-energy meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total ad-libitum energy intake
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.
Measured: The feeding test will be conducted 6.5 hours after the high-fat, high-energy meal.
Secondary outcomes (5)
Food liking
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: Measured during the screening visit.
Body composition
Whole-body and regional body composition assessed by dual-energy X-ray absorptiometry (DXA).
Measured: Measured during a dedicated body composition assessment visit.
Subjective appetite sensations
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.
Measured: Repeatedly measured during the metabolic test before and following consumption of the high-fat, high-energy meal.
Energy expenditure and fuel oxidation
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.
Measured: Repeatedly measured during the metabolic test before and following consumption of the high-fat, high-energy meal.
Circulating metabolite and hormonal concentrations
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.
Measured: Repeatedly measured during the metabolic test before and following consumption of the high-fat, high-energy meal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start23 Mar 2023
- Primary completion16 Jan 2026
- Study completion16 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy UnderweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jose Galgani
- Sponsor type
- University, hospital or other
- Collaborators
- Agencia Nacional de Investigación y Desarrollo
- Responsible party
- Sponsor-investigator, Jose Galgani, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671105
- Sponsor's protocol ID
- 210624007
- Acronym
- PROB I
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Flexibility, Eating Behavior and Adipose Tissue Expandability: Role of This Triad in the Propensity to Human Obesity
- ClinicalTrials.gov ID
- NCT07671105
- Acronym / sponsor ID
- PROB I / 210624007
- Conditions
- Healthy Underweight, Normal Weight Adults
- Keywords
- Healthy underweight, Energy metabolism, Energy intake, Food preferences, Eating behavior, High-fat feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Jose GalganiUniversity, hospital or other
- Collaborators
- Agencia Nacional de Investigación y Desarrollo
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- 16 Jan 2026 (actual)
- Study completion
- 16 Jan 2026 (actual)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-fat, high-energy meal | Experimental | Other: High-fat high-energy mealHealthy 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-fat high-energy mealFollowing 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. | Other | High-fat, high-energy meal |
Primary outcome
Total ad-libitum energy intake
Time frame: 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.
5 secondary outcomes
Food liking
Time frame: Measured during the screening visit.
Body composition
Time frame: Measured during a dedicated body composition assessment visit.
Subjective appetite sensations
Time frame: Repeatedly measured during the metabolic test before and following consumption of the high-fat, high-energy meal.
Energy expenditure and fuel oxidation
Time frame: Repeatedly measured during the metabolic test before and following consumption of the high-fat, high-energy meal.
Circulating metabolite and hormonal concentrations
Time frame: Repeatedly measured during the metabolic test before and following consumption of the high-fat, high-energy meal.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-fat high-energy meal in people with Healthy Underweight and Normal Weight Adults, run by Jose Galgani at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total ad-libitum energy intake (time frame: The feeding test will be conducted 6.5 hours after the high-fat, high-energy meal.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.