Obesity (Disorder)TEFAONCT07233174
Postprandial Thermogenesis in Obese Adolescents: Effect of Meal Calorie Content
A study testing Energy expenditure and energy substrates, Food sensations and Liking & Wanting in people with Obesity (Disorder), run by Centre Hospitalier Emile Roux at 1 site in France.
Trial summary
The prevention and management of pediatric obesity require a thorough understanding and consideration of the different components of energy balance (i.e., intake and expenditure) and their interactions. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Obesity (Disorder)
- What is being tested?
- Energy expenditure and energy substrates, Food sensations and Liking & Wanting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 3 Dec 2025to 21 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 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • Adolescents aged 11 to 17 (inclusive), at Tanner stage 3-5 of sexual maturation,
- With obesity defined as a body mass index (BMI) above the 97th percentile according to national growth charts,
- Adolescents affiliated with the social security system or equivalent,
- Adolescents who have been informed and have given their written consent to participate in the study.
Who cannot join
- Refusal to participate in the study,
- Refusal of consent by legal guardians,
- Regular consumption of tobacco or alcohol,
- Special diet,
- Participation in regular and intense physical and sporting activities,
- Medical or surgical history deemed by the investigator to be incompatible with the study,
Show all 15Show fewer
- Presence of diabetes, and any other condition limiting the application of either strategy being tested,
- Adolescents undergoing energy restriction or a weight loss program through physical activity at the time of inclusion or during the last 6 months,
- Taking medication that may interfere with the study results.
- Adolescents with cardiovascular problems, i.e., subjects with a history of cardiovascular and/or neurovascular disease, as well as subjects with cardiovascular and/or neurovascular risk factors (excluding obesity/overweight).
- Surgery in the previous 3 months,
- Adolescents who are currently excluded from another study,
- Pregnant or breastfeeding adolescents,
- Adolescents under guardianship/curatorship or legal protection,
- Parents under guardianship/curatorship or legal protection.
Trial locations and contacts
1 site in 1 country.
About this study
The prevention and management of pediatric obesity require a thorough understanding and consideration of the different components of energy balance (i.e., intake and expenditure) and their interactions. Total energy expenditure (TEE) consists of resting metabolism (RM), energy expenditure induced by physical activity (EEPA), and dietary thermogenesis (DTE). While RM and EEPA are the two main contributors to TEE, DTE is often overlooked, even though it can account for around 10% of our daily energy expenditure. In fact, few studies have prioritized the evaluation of the thermic effect of food (TEF), defined as the increase in energy expenditure above the basal metabolic rate when fasting, despite the fact that it accounts for about 10% of total daily energy expenditure . It has been suggested that TEF may play a role in the development or maintenance of obesity.
Some studies indicate a reduction in TEF in individuals living with obesity , possibly due to lower postprandial activation of the sympathetic nervous system, thereby limiting the thermogenic response after meals . Conversely, several studies have reported no decrease in TEF in individuals living with obesity . Due to these contradictory results, no consensus has been reached on the FET response in individuals with obesity compared to those of normal weight.
Read more
The limited number of available results can be explained not only by a lack of interest in this TEF among scientists and clinicians, but also by the methodological difficulties involved in its assessment. Indeed, the latter requires indirect calorimetry measurements over a period of up to 5 to 6 hours after a meal, as well as careful calibration of the test meals used, their qualitative content, and their caloric content. These factors are all the more important to consider given that a systematic review has shown that TEF is influenced by the energy intake of the meal as well as its macronutrient composition, with proteins and carbohydrates inducing a higher TEF than lipids . However, several uncertainties remain, particularly regarding the choice of test meal, which could be standardized for all participants or adjusted according to their body composition.
While our team recently conducted a systematic review of the literature in this area, identifying a glaring lack of evidence, the few results available suggest a potential reduction in TEF in obese children and adolescents, contributing to a minimization of the optimization of their daily energy balance. In their study, Maffeis and colleagues show, for example, a significantly reduced TEF in adolescents with obesity compared to their normal-weight counterparts, despite a higher-calorie test meal adapted to their energy needs . These results are consistent with those proposed by Salas-Salvado the following year, who suggested a reduced TEF in obese adolescents, associated with their percentage of body fat . This research suggests the need to consider the effects of weight status, body composition, and the caloric composition of a meal in order to better understand TEF in this population.
Unfortunately, this area has not been explored in depth since the 1990s, even though the prevalence of pediatric obesity continues to rise.
In this context, the objective of this study is to explore dietary thermogenesis in response to meals of different caloric content in obese adolescents.
- Conditions
- Obesity (Disorder)
- Being tested
- Energy expenditure and energy substrates, Food sensations, Liking & Wanting
- Keywords
- obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy expenditure and energy substratesOther
- Three randomized experimental visits to the AME2P laboratory with a minimum interval of five days between each visit with:
- one test meal with a different calorie content but the same macronutrient distribution: i) a 700 kcal meal (C-700); ii) a 1000 kcal meal (C-1000); iii) a 1300 kcal meal (C-1300).
- Energy expenditure and energy substrates: at the adolescents' arrival at the laboratory (20 min), then for 20 min before the test meal at noon, then for one hour immediately after the meal, then for 15 min every 45 min after the meal for 4 hours.
Mesured using portable indirect calorimetry (MetaMax, Inc.).
Food sensationsOther
At regular intervals throughout the experimental days, participants will be asked to complete visual analog scales (VAS) to report their feelings of hunger, satiety, or desire to eat. Measurements will be taken before and after breakfast, same for the test lunch, and then every 30 min until 5 p.m.
Liking & WantingOther
Their relationship with food will be investigated 15 min before the test meal and then 1 hour after, using the Leeds Foods Preference Questionnaire developed and validated by the team led by Professor Blundell. The adolescents will be asked to answer a series of questions about their food preferences by selecting their favorite foods from a selection of images during a 10-min computer exercise. Similarly, during this exercise, they are asked to use a visual analog scale to estimate how much they would like to eat certain foods presented. Based on their choices and the time taken to respond, the LFPQ assesses the adolescents' degree of "liking" and "wanting." The adolescents must complete this exercise 15 minutes before and after the evening test meal. To avoid any influence on food intake at the next meal, the foods presented during the test are not foods presented during the meal. The objective of this exercise is to assess the response of "liking" and "wanting" to food intake.
| Study group | Role | What they receive |
|---|---|---|
| Adolescents aged 11 to 17 with obesity | Experimental | Not described Receives: Other: Energy expenditure and energy substrates; Other: Food sensations; Other: Liking & Wanting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial energy expenditure (PEE) in response to meals.
Energy expenditure and energy substrates will be assessed in the morning upon arrival at the laboratory (20 minutes), then for 20 minutes before the test meal at noon, then for one hour immediately after the meal, then for 15 minutes every 45 minutes after the meal for 4 hours (a total of 5 hours of post-meal measurements).
These measurements will be performed using portable indirect calorimetry (MetaMax, Inc.). Indirect calorimetry is one of the classic methods for measuring resting energy expenditure . The contribution of lipid and carbohydrate oxidation will be calculated indirectly by monitoring oxygen consumption and CO2 rejection according to double unknown equations, considering that protein oxidation is stable and around 15% .
The MetaMax is a mask that causes no physical or respiratory discomfort and is connected to a gas analyzer. This technology has been used regularly in adolescents with and without obesity by our team and other teams .
Measured: Visit 1, Visit 2, Visit 3
Secondary outcomes (2)
Appetite sensations in response to meals
At regular intervals throughout the experimental days, participants will be asked to complete Visual Analog Scales to report their feelings of hunger, satiety, or desire to eat. Measurements will be taken before and after breakfast, before and after the test lunch, and then every 30 minutes until 5 p.m.
Participants will be asked questions such as, if hungry or not, and will quantify their feelings on a scale of 0mm to 150mm, with 0mm corresponding to the minimum and "Not at all" and 150mm to the maximum and "Extremely." These scales, proposed and validated by Flint and colleagues in 2001 (Flint Scale), have been used in adults and children, both thin and obese, and have shown high reliability of results.
Measured: Visit 1, Visit 2, Visit 3
The hedonic response as measured by food liking and wanting
The study examines adolescents' relationship with food using the Leeds Food Preference Questionnaire. During a 10-minute computer task, participants choose preferred foods from images and rate how much they would like to eat each item using visual analogue scales. Their reaction times and ratings allow researchers to measure both "liking" and "wanting." The task is completed 15 minutes before and after the evening test meal, and the foods shown differ from those served to avoid influencing intake. Liking is rated on a scale from 0 ("not pleasant at all") to 100 ("extremely pleasant"), with higher scores indicating stronger liking. Wanting is measured on a similar scale from 0 ("do not want at all") to 100 ("strongly want to eat"), where higher scores reflect greater motivational desire for the food.
Measured: Visit 1, Visit 2, Visit 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start3 Dec 2025
- Primary completion21 Jan 2026
- Study completion21 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity (Disorder)Studies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Emile Roux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David THIVEL, Principal investigator, Director of AME2P Laboratory, Clermont Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233174
- Sponsor's protocol ID
- RIPH2_GADEA_TEFAO
- Other IDs
- 2025-A01847-42
- Acronym
- TEFAO
- Status last verified
- Feb 2026
- First submitted
- 14 Nov 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Thermogenesis in Obese Adolescents: Effect of Meal Calorie Content
- ClinicalTrials.gov ID
- NCT07233174
- Acronym / sponsor ID
- TEFAO / RIPH2_GADEA_TEFAO
- Conditions
- Obesity (Disorder)
- Keywords
- obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre Hospitalier Emile RouxUniversity, hospital or other
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- 21 Jan 2026 (actual)
- Study completion
- 21 Jan 2026 (actual)
- First posted
- 18 Nov 2025 (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.
The prevention and management of pediatric obesity require a thorough understanding and consideration of the different components of energy balance (i.e., intake and expenditure) and their interactions. Total energy expenditure (TEE) consists of resting metabolism (RM), energy expenditure induced by physical activity (EEPA), and dietary thermogenesis (DTE). While RM and EEPA are the two main contributors to TEE, DTE is often overlooked, even though it can account for around 10% of our daily energy expenditure. In fact, few studies have prioritized the evaluation of the thermic effect of food (TEF), defined as the increase in energy expenditure above the basal metabolic rate when fasting, despite the fact that it accounts for about 10% of total daily energy expenditure . It has been suggested that TEF may play a role in the development or maintenance of obesity.
Some studies indicate a reduction in TEF in individuals living with obesity , possibly due to lower postprandial activation of the sympathetic nervous system, thereby limiting the thermogenic response after meals . Conversely, several studies have reported no decrease in TEF in individuals living with obesity . Due to these contradictory results, no consensus has been reached on the FET response in individuals with obesity compared to those of normal weight.
The limited number of available results can be explained not only by a lack of interest in this TEF among scientists and clinicians, but also by the methodological difficulties involved in its assessment. Indeed, the latter requires indirect calorimetry measurements over a period of up to 5 to 6 hours after a meal, as well as careful calibration of the test meals used, their qualitative content, and their caloric content. These factors are all the more important to consider given that a systematic review has shown that TEF is influenced by the energy intake of the meal as well as its macronutrient composition, with proteins and carbohydrates inducing a higher TEF than lipids . However, several uncertainties remain, particularly regarding the choice of test meal, which could be standardized for all participants or adjusted according to their body composition.
While our team recently conducted a systematic review of the literature in this area, identifying a glaring lack of evidence, the few results available suggest a potential reduction in TEF in obese children and adolescents, contributing to a minimization of the optimization of their daily energy balance. In their study, Maffeis and colleagues show, for example, a significantly reduced TEF in adolescents with obesity compared to their normal-weight counterparts, despite a higher-calorie test meal adapted to their energy needs . These results are consistent with those proposed by Salas-Salvado the following year, who suggested a reduced TEF in obese adolescents, associated with their percentage of body fat . This research suggests the need to consider the effects of weight status, body composition, and the caloric composition of a meal in order to better understand TEF in this population.
Unfortunately, this area has not been explored in depth since the 1990s, even though the prevalence of pediatric obesity continues to rise.
In this context, the objective of this study is to explore dietary thermogenesis in response to meals of different caloric content in obese adolescents.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescents aged 11 to 17 with obesity | Experimental | Other: Energy expenditure and energy substrates, Other: Food sensations, Other: Liking & Wanting |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- • Adolescents aged 11 to 17 (inclusive), at Tanner stage 3-5 of sexual maturation,
Key exclusion criteria (15 listed)
- Refusal to participate in the study,
- Refusal of consent by legal guardians,
- Regular consumption of tobacco or alcohol,
- Special diet,
- Participation in regular and intense physical and sporting activities,
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 |
|---|---|---|
| Energy expenditure and energy substrates* Three randomized experimental visits to the AME2P laboratory with a minimum interval of five days between each visit with: * one test meal with a different calorie content but the same macronutrient distribution: i) a 700 kcal meal (C-700); ii) a 1000 kcal meal (C-1000); iii) a 1300 kcal meal (C-1300). * Energy expenditure and energy substrates: at the adolescents' arrival at the laboratory (20 min), then for 20 min before the test meal at noon, then for one hour immediately after the meal, then for 15 min every 45 min after the meal for 4 hours. Mesured using portable indirect calorimetry (MetaMax, Inc.). | Other | Adolescents aged 11 to 17 with obesity |
| Food sensationsAt regular intervals throughout the experimental days, participants will be asked to complete visual analog scales (VAS) to report their feelings of hunger, satiety, or desire to eat. Measurements will be taken before and after breakfast, same for the test lunch, and then every 30 min until 5 p.m. | Other | Adolescents aged 11 to 17 with obesity |
| Liking & WantingTheir relationship with food will be investigated 15 min before the test meal and then 1 hour after, using the Leeds Foods Preference Questionnaire developed and validated by the team led by Professor Blundell. The adolescents will be asked to answer a series of questions about their food preferences by selecting their favorite foods from a selection of images during a 10-min computer exercise. Similarly, during this exercise, they are asked to use a visual analog scale to estimate how much they would like to eat certain foods presented. Based on their choices and the time taken to respond, the LFPQ assesses the adolescents' degree of "liking" and "wanting." The adolescents must complete this exercise 15 minutes before and after the evening test meal. To avoid any influence on food intake at the next meal, the foods presented during the test are not foods presented during the meal. The objective of this exercise is to assess the response of "liking" and "wanting" to food intake. | Other | Adolescents aged 11 to 17 with obesity |
Primary outcome
Postprandial energy expenditure (PEE) in response to meals.
Time frame: Visit 1, Visit 2, Visit 3
Energy expenditure and energy substrates will be assessed in the morning upon arrival at the laboratory (20 minutes), then for 20 minutes before the test meal at noon, then for one hour immediately after the meal, then for 15 minutes every 45 minutes after the meal for 4 hours (a total of 5 hours of post-meal measurements). These measurements will be performed using portable indirect calorimetry (MetaMax, Inc.). Indirect calorimetry is one of the classic methods for measuring resting energy expenditure . The contribution of lipid and carbohydrate oxidation will be calculated indirectly by monitoring oxygen consumption and CO2 rejection according to double unknown equations, considering that protein oxidation is stable and around 15% . The MetaMax is a mask that causes no physical or respiratory discomfort and is connected to a gas analyzer. This technology has been used regularly in adolescents with and without obesity by our team and other teams .
2 secondary outcomes
Appetite sensations in response to meals
Time frame: Visit 1, Visit 2, Visit 3
The hedonic response as measured by food liking and wanting
Time frame: Visit 1, Visit 2, Visit 3
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 12 Feb 2026.
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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.
David THIVEL principal investigator
Director of AME2P Laboratory, Clermont Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Energy expenditure and energy substrates, Food sensations and Liking & Wanting in people with Obesity (Disorder), run by Centre Hospitalier Emile Roux at 1 site in France.
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 4 inclusion and 15 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 12 Feb 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 France. 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?
Postprandial energy expenditure (PEE) in response to meals. (time frame: Visit 1, Visit 2, Visit 3). 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 12 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.