Anorexia NervosaNutrileanNCT03981432
Energy Intake, Exercise and Constitutional Leanness
A study testing REST-Fixed, REST-AdLib and EX-AdLib in people with Anorexia Nervosa and Constitutional Leanness, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The aim of this study will be to identify the physical and dietary profile of adult women presenting constitutional leanness (CL), comparatively with normal-weight peers and BMI-matched women with anorexia nervosa. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa, Constitutional Leanness
- What is being tested?
- REST-Fixed, REST-AdLib and EX-AdLib
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 16 Apr 2021to 14 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Common criteria to the three groups
- Women
- Aged 18 to 35 years old
- -- Signed consent form
- being registered in the national social security system
- no contraindication to physical activity
Show all 21Show fewer
- Criteria specific to constitutionally lean women
- BMI ≤ 17.5 kg/m2
- Weight stable for the last three months
- No dietary disorders
- no sign of denutrition
- absence of amenorrhea
- Criteria specific to women with anorexia nervosa
- BMI ≤ 17.5 kg/m2
- Pure restrictive Anorxia nevrosa: no binge eating or vomiting episodes for the last thress months.
- DSM V (2013) crietria Criteria specific to normal weight women
- 20 kg/m2 ≤ BMI ≤ 25 kg/m2
- Weight stable for the last three months
- No dietary disorders
- no sign of denutrition
- absence of amenorrhea
Who cannot join
- Pregnancy
- Intensive physical activity level (aboce 3 sessions per week)
- Impaired level of IGF-1, estradiol, T3free, cortisol and leptin (for normal weight and constitutionally lean women)
- Previous surgical interventions that is considered as non-compatible with the study.
- Diabetes
- Medication that could interfer with the study.
- cardiovascular disease or risks
- Surgery within the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of the Physical and Dietary Profile on Constitutionally Lean People: the NUTRILEAN Study
The aim of this study will be to identify the physical and dietary profile of adult women presenting constitutional leanness (CL), comparatively with normal-weight peers and BMI-matched women with anorexia nervosa. After an evaluation of their daily energy intake, physical activity level, body composition, aerobic capacities and muscle strength, women from the normal weight and CL groups will be asked to realized laboratory sessions to evaluate their energy intake and appetite feelings responses to acute exercise
Read the detailed description
Body composition (using X-ray absorptiometry), muscle strength (biodex), daily energy intake (dietary record), food preferences (Leeds Food Preference Questionnaire) and physical activity level (GT3X accelerometers) will be assessed among women with constitutional leanness normal weight women and women with anorexia nervosa. The CT and NW groups will then be asked to randomly realized three experimental session: i) a rest session with an fixed lunch meal; a rest session with an ad libitum meal ; iii) an exercise session with an ad libitum meal. Their ad libitum energy intake will be assessed during the two last sessions. Appetite feelings will be assessed at regular intervals and their food reward in response to the lunch will also be assessed.
- Conditions
- Anorexia Nervosa, Constitutional Leanness
- Being tested
- REST-Fixed, REST-AdLib, EX-AdLib
- Keywords
- appetite control, leanness, physical fitness
- Medical subject headings
- Anorexia Nervosa, Thinness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REST-FixedBehavioural
condition without exercise / rest condition. The participants will be asked to remain quiet and at rest during the morning and will receive a fixed meal at lunch. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.
REST-AdLibBehavioural
condition without exercise / rest condition. The participants will be asked to remain quiet and at rest during the morning and will receive an ad libitum meal at lunch. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.
EX-AdLibBehavioural
condition with an acute exercise set 30 minutes before the lunch meal that will be served ad libitum This will be a 30-minute exercise set at 65% of their capacities (cycling), 30 minutes before lunch.
| Study group | Role | What they receive |
|---|---|---|
| Constitutional leanness | Experimental | Constitutional leanness Receives: Behavioral: REST-Fixed; Behavioral: REST-AdLib; Behavioral: EX-AdLib |
| Normal weight | Experimental | Normal weight women Receives: Behavioral: REST-Fixed; Behavioral: REST-AdLib; Behavioral: EX-AdLib |
| Anorexia nevrosa | Experimental | women presenting Anorexia nevrosa Receives: Behavioral: REST-Fixed; Behavioral: REST-AdLib; Behavioral: EX-AdLib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in energy intake measured during the ad libitum buffet meal (in kcal).
food intake will be measured ad libitum during a lunch buffet. The participants 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 Bilnuts software.
Measured: day 1 , day 8
Secondary outcomes (7)
Body fat mass
the percentage of body fat and the quantity of fat mass will be assessed using X-ray absorptiometry (DXA)
Measured: day 1
fat free mass
the percentage of body fat and the quantity of fat mass will be assessed using X-ray absorptiometry (DXA)
Measured: day 1
Physical activity level
The time spent at low-moderate and vigorous physical activity will be assessed using a 7-day accelerometry record (Actigraph GT3X)
Measured: day 1
Daily energy intake
The amount and quality of food intake will be assessed using a three-day dietary record
Measured: Trough 3 days
Food reward
The participants will be asked to complete a validated computer-based procedure to measure food reward (Leeds Food Preference Questionnaire; LFPQ)
Measured: day 1 , day 8 , day 15
change in energy intake measured during the ad libitum buffet meal (in kcal).
food intake will be measured ad libitum during a lunch buffet. The participants 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 Bilnuts software
Measured: day 1 , day 8
Hunger feelings
hunger area under the curve will be assessed using visual analogue scale through a the day using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation)
Measured: day 1 , day 8 , day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start16 Apr 2021
- Primary completion14 Nov 2023
- Study completion14 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- all participants receive the same intervention
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
- Responsible party
- Sponsor
- Investigators
- Martine Duclos, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981432
- Sponsor's protocol ID
- RBHP 2018 DUCLOS 3
- Acronym
- Nutrilean
- Status last verified
- Jul 2026
- First submitted
- 29 Apr 2019
- Last updated
- 3 Aug 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 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of the Physical and Dietary Profile on Constitutionally Lean People: the NUTRILEAN Study
- ClinicalTrials.gov ID
- NCT03981432
- Acronym / sponsor ID
- Nutrilean / RBHP 2018 DUCLOS 3
- Conditions
- Anorexia Nervosa, Constitutional Leanness
- Keywords
- appetite control, leanness, physical fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- 14 Nov 2023 (actual)
- Study completion
- 14 Nov 2023 (actual)
- First posted
- 10 Jun 2019 (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 this study will be to identify the physical and dietary profile of adult women presenting constitutional leanness (CL), comparatively with normal-weight peers and BMI-matched women with anorexia nervosa. After an evaluation of their daily energy intake, physical activity level, body composition, aerobic capacities and muscle strength, women from the normal weight and CL groups will be asked to realized laboratory sessions to evaluate their energy intake and appetite feelings responses to acute exercise
Detailed description
Body composition (using X-ray absorptiometry), muscle strength (biodex), daily energy intake (dietary record), food preferences (Leeds Food Preference Questionnaire) and physical activity level (GT3X accelerometers) will be assessed among women with constitutional leanness normal weight women and women with anorexia nervosa. The CT and NW groups will then be asked to randomly realized three experimental session: i) a rest session with an fixed lunch meal; a rest session with an ad libitum meal ; iii) an exercise session with an ad libitum meal. Their ad libitum energy intake will be assessed during the two last sessions. Appetite feelings will be assessed at regular intervals and their food reward in response to the lunch will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- all participants receive the same intervention
| Arm | Type | Receives |
|---|---|---|
| Constitutional leanness | Experimental | Behavioral: REST-Fixed, Behavioral: REST-AdLib, Behavioral: EX-AdLibConstitutional leanness |
| Normal weight | Experimental | Behavioral: REST-Fixed, Behavioral: REST-AdLib, Behavioral: EX-AdLibNormal weight women |
| Anorexia nevrosa | Experimental | Behavioral: REST-Fixed, Behavioral: REST-AdLib, Behavioral: EX-AdLibwomen presenting Anorexia nevrosa |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- Common criteria to the three groups
- Women
- Aged 18 to 35 years old
- -- Signed consent form
- being registered in the national social security system
Key exclusion criteria (8 listed)
- Pregnancy
- Intensive physical activity level (aboce 3 sessions per week)
- Impaired level of IGF-1, estradiol, T3free, cortisol and leptin (for normal weight and constitutionally lean women)
- Previous surgical interventions that is considered as non-compatible with the study.
- Diabetes
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 |
|---|---|---|
| REST-Fixedcondition without exercise / rest condition. The participants will be asked to remain quiet and at rest during the morning and will receive a fixed meal at lunch. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals. | Behavioural | Anorexia nevrosa, Constitutional leanness, Normal weight |
| REST-AdLibcondition without exercise / rest condition. The participants will be asked to remain quiet and at rest during the morning and will receive an ad libitum meal at lunch. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals. | Behavioural | Anorexia nevrosa, Constitutional leanness, Normal weight |
| EX-AdLibcondition with an acute exercise set 30 minutes before the lunch meal that will be served ad libitum This will be a 30-minute exercise set at 65% of their capacities (cycling), 30 minutes before lunch. | Behavioural | Anorexia nevrosa, Constitutional leanness, Normal weight |
Primary outcome
Change in energy intake measured during the ad libitum buffet meal (in kcal).
Time frame: day 1 , day 8
food intake will be measured ad libitum during a lunch buffet. The participants 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 Bilnuts software.
7 secondary outcomes
Body fat mass
Time frame: day 1
fat free mass
Time frame: day 1
Physical activity level
Time frame: day 1
Daily energy intake
Time frame: Trough 3 days
Food reward
Time frame: day 1 , day 8 , day 15
change in energy intake measured during the ad libitum buffet meal (in kcal).
Time frame: day 1 , day 8
Hunger feelings
Time frame: day 1 , day 8 , day 15
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.
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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.
Martine Duclos 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 REST-Fixed, REST-AdLib and EX-AdLib in people with Anorexia Nervosa and Constitutional Leanness, 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 21 inclusion and 8 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?
Change in energy intake measured during the ad libitum buffet meal (in kcal). (time frame: day 1 , day 8). 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 3 Aug 2026.