ObesityNEXTNCT05365685
Energy Turnover and Appetite
A study testing Low energy turnover in people with Obesity, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The aim of the study is to compare the effect of a low versus moderate versus high energy turnover on energy intake, appetite and food reward, in adolescents with obesity. 18 adolescents with obesity will then complete three experimental sessions in a randomized order: low, high and moderate Energy turnover. Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Obesity
- What is being tested?
- Low energy turnover
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 27 Aug 2022to 8 Nov 2023
- 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 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- BMI percentile > 97th percentile according to the french curves.
- ages 12-16 years old
- Signed consent form
- being registered in the national social security system
- no contraindication to physical activity
Who cannot join
- Previous surgical interventions that is considered as non-compatible with the study.
- Diabetes
- weight loss during the last 6 months
- cardiovascular disease or risks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Degree of Energy Turnover on Appetitive Responses in Adolescents With Obesity
The aim of the study is to compare the effect of a low versus moderate versus high energy turnover on energy intake, appetite and food reward, in adolescents with obesity. 18 adolescents with obesity will then complete three experimental sessions in a randomized order: low, high and moderate Energy turnover.
Read the detailed description
A total of 18 adolescents with obesity, aged 12-16 years olds will complete three experimental sessions in a randomized order: i) low energy turnover; ii) Moderate energy turnover and ; iii) High energy turnover. Their ad libitum energy intake at dinner will be assessed through an ad libitum buffet-type meal, their food reward assessed right before the dinner meal and their appetite sensation at regular intervals during the day.
- Conditions
- Obesity
- Being tested
- Low energy turnover
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low energy turnoverBehavioural
Also called Moderate energy turnover, High energy turnover
Low Energy Turnover. The adolescents with ingest low energy intake at lunch and breakfast and will not perform physical exercise during the day. The will will receive an ad libitum meal at dinner time. Their food reward will be assessed before dinner. Their appetite feelings will be assessed at regular intervals.
Moderate Energy Turnover. The adolescents with ingest moderate energy intake at lunch and breakfast and will perform one 45 minutes physical exercise during the day. The will will receive an ad libitum meal at dinner time. Their food reward will be assessed before dinner. Their appetite feelings will be assessed at regular intervals.
High Energy Turnover. The adolescents with ingest high energy intake at lunch and breakfast and will perform two 45-minute physical exercises during the day. The will will receive an ad libitum meal at dinner time. Their food reward will be assessed before dinner. Their appetite feelings will be assessed at regular intervals.
| Study group | Role | What they receive |
|---|---|---|
| adolescents with obesity | Experimental | There is only one arm as this is an acute randomized study comparing three different conditions within the same sample of participants. Receives: Behavioral: Low energy turnover |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy intake measured during an ad libitum buffet meal (in kcal).
food intake will be measured ad libitum during a dinner buffet. The adolescents will be offered an ad libitum buffet-type meal composed based on their food intake preferences. Their intake will be weighted using an electronic food scale by a member of the investigation team and then analysed using a nutritional software.
Measured: it will be assessed at dinner baseline
Secondary outcomes (2)
Hunger feelings
hunger area under the curve will be assessed using visual analogue scale through a the day
Measured: immediately after breakfast/lunch/dinner on day 1
Food reward
: The participants will be asked to complete a validated computer-based procedure to measure food reward (Leeds Food Preference Questionnaire; LFPQ). Briefly, the LFPQ provides measures of the wanting and liking for an array of food images, varying in both fat content and taste.
Measured: it will be assessed at dinner baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start27 Aug 2022
- Primary completion29 Oct 2022
- Study completion8 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves BOIRIE, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365685
- Sponsor's protocol ID
- RBHP 2021 BOIRIE 2
- Other IDs
- 2021-A02867-34
- Acronym
- NEXT
- Status last verified
- Jul 2026
- First submitted
- 29 Mar 2022
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moore H, Pereira B, Fillon A, Miguet M, Masurier J, Beaulieu K, Finlayson G, Thivel D. The association between obesity severity and food reward in adolescents with obesity: a one-stage individual participant data meta-analysis. Eur J Nutr. 2024 Jun;63(4):1241-1255. doi: 10.1007/s00394-024-03348-4. Epub 2024 Feb 20.
PubMed 38376518
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Degree of Energy Turnover on Appetitive Responses in Adolescents With Obesity
- ClinicalTrials.gov ID
- NCT05365685
- Acronym / sponsor ID
- NEXT / RBHP 2021 BOIRIE 2
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 27 Aug 2022 (actual)
- Primary completion
- 29 Oct 2022 (actual)
- Study completion
- 8 Nov 2023 (actual)
- First posted
- 9 May 2022 (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 aim of the study is to compare the effect of a low versus moderate versus high energy turnover on energy intake, appetite and food reward, in adolescents with obesity. 18 adolescents with obesity will then complete three experimental sessions in a randomized order: low, high and moderate Energy turnover.
Detailed description
A total of 18 adolescents with obesity, aged 12-16 years olds will complete three experimental sessions in a randomized order: i) low energy turnover; ii) Moderate energy turnover and ; iii) High energy turnover. Their ad libitum energy intake at dinner will be assessed through an ad libitum buffet-type meal, their food reward assessed right before the dinner meal and their appetite sensation at regular intervals during the day.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adolescents with obesity | Experimental | Behavioral: Low energy turnoverThere is only one arm as this is an acute randomized study comparing three different conditions within the same sample of participants. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- BMI percentile > 97th percentile according to the french curves.
- ages 12-16 years old
- Signed consent form
- being registered in the national social security system
- no contraindication to physical activity
Key exclusion criteria (4 listed)
- Previous surgical interventions that is considered as non-compatible with the study.
- Diabetes
- weight loss during the last 6 months
- cardiovascular disease or risks
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 |
|---|---|---|
| Low energy turnoverAlso: Moderate energy turnover, High energy turnoverLow Energy Turnover. The adolescents with ingest low energy intake at lunch and breakfast and will not perform physical exercise during the day. The will will receive an ad libitum meal at dinner time. Their food reward will be assessed before dinner. Their appetite feelings will be assessed at regular intervals. Moderate Energy Turnover. The adolescents with ingest moderate energy intake at lunch and breakfast and will perform one 45 minutes physical exercise during the day. The will will receive an ad libitum meal at dinner time. Their food reward will be assessed before dinner. Their appetite feelings will be assessed at regular intervals. High Energy Turnover. The adolescents with ingest high energy intake at lunch and breakfast and will perform two 45-minute physical exercises during the day. The will will receive an ad libitum meal at dinner time. Their food reward will be assessed before dinner. Their appetite feelings will be assessed at regular intervals. | Behavioural | adolescents with obesity |
Primary outcome
Energy intake measured during an ad libitum buffet meal (in kcal).
Time frame: it will be assessed at dinner baseline
food intake will be measured ad libitum during a dinner buffet. The adolescents will be offered an ad libitum buffet-type meal composed based on their food intake preferences. Their intake will be weighted using an electronic food scale by a member of the investigation team and then analysed using a nutritional software.
2 secondary outcomes
Hunger feelings
Time frame: immediately after breakfast/lunch/dinner on day 1
Food reward
Time frame: it will be assessed at dinner baseline
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 3 Aug 2026.
- Derived from this study: PubMed 38376518Moore H, Pereira B, Fillon A, Miguet M, Masurier J, Beaulieu K, Finlayson G, Thivel D. The association between obesity severity and food reward in adolescents with obesity: a one-stage individual participant data meta-analysis. Eur J Nutr. 2024 Jun;63(4):1241-1255. doi: 10.1007/s00394-024-03348-4. Epub 2024 Feb 20.
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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.
Yves BOIRIE principal investigator
University Hospital, 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 Low energy turnover in people with Obesity, run by University Hospital, Clermont-Ferrand 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 5 inclusion and 4 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 3 Aug 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?
Energy intake measured during an ad libitum buffet meal (in kcal). (time frame: it will be assessed at dinner baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05365685, which also lists 1 linked publication.
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 3 Aug 2026.