NCT07233174

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

December 3, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2026

Completed
Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

November 14, 2025

Last Update Submit

February 10, 2026

Conditions

Keywords

obesity

Outcome Measures

Primary Outcomes (1)

  • 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 .

    Visit 1, Visit 2, Visit 3

Secondary Outcomes (2)

  • Appetite sensations in response to meals

    Visit 1, Visit 2, Visit 3

  • The hedonic response as measured by food liking and wanting

    Visit 1, Visit 2, Visit 3

Study Arms (1)

Adolescents aged 11 to 17 with obesity

EXPERIMENTAL
Other: Energy expenditure and energy substratesOther: Food sensationsOther: Liking & Wanting

Interventions

* 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.).

Adolescents aged 11 to 17 with obesity

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.

Adolescents aged 11 to 17 with obesity

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.

Adolescents aged 11 to 17 with obesity

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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,
  • Presence of diabetes, and any other condition limiting the application of either strategy being tested,
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory AME2P, University of Clermont Auvergne

Aubière, 63170, France

Location

MeSH Terms

Conditions

Obesity

Interventions

Energy Metabolism

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metabolism

Study Officials

  • David THIVEL

    Director of AME2P Laboratory, Clermont Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 18, 2025

Study Start

December 3, 2025

Primary Completion

January 21, 2026

Study Completion

January 21, 2026

Last Updated

February 12, 2026

Record last verified: 2026-02

Locations