Postprandial Thermogenesis in Obese Adolescents: Effect of Meal Calorie Content

NCT ID: NCT07233174

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-03

Study Completion Date

2027-12-15

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity (Disorder)

Keywords

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obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Adolescents aged 11 to 17 with obesity

Group Type EXPERIMENTAL

Energy expenditure and energy substrates

Intervention Type OTHER

* 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 sensations

Intervention Type OTHER

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 & Wanting

Intervention Type OTHER

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.

Interventions

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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.).

Intervention Type OTHER

Food sensations

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.

Intervention Type OTHER

Liking & Wanting

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* • 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.

Exclusion Criteria

* 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,
* 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.
Minimum Eligible Age

11 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Emile Roux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David THIVEL

Role: PRINCIPAL_INVESTIGATOR

Director of AME2P Laboratory, Clermont Ferrand

Locations

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Laboratory AME2P, University of Clermont Auvergne

Aubière, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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David THIVEL Director of AME2P Laboratory, Clermont Ferrand

Role: CONTACT

Phone: +0033 4 73 40 76 79

Email: [email protected]

Marie PEURIERE Clinical Research Projects Manager

Role: CONTACT

Phone: +0033471043538

Email: [email protected]

Facility Contacts

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David THIVEL Director of AME2P Laboratory

Role: primary

Other Identifiers

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2025-A01847-42

Identifier Type: OTHER

Identifier Source: secondary_id

RIPH2_GADEA_TEFAO

Identifier Type: -

Identifier Source: org_study_id