ClinicalTrials.gg
CompletedNCT03981432NutrileanUpdated Aug 3, 2026

Energy Intake, Exercise and Constitutional Leanness

An interventional study of REST-Fixed and REST-AdLib in Anorexia Nervosa and Constitutional Leanness, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-03.

Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Anorexia Nervosa
  • Constitutional Leanness

Keywords

  • appetite control
  • leanness
  • physical fitness
03

In context

Anorexia Nervosa

469 studies on the registry are indexed under Anorexia Nervosa; 127 are open to participants now.

This study's enrollment of 34 is below the median of 46 across 313 interventional studies indexed under Anorexia Nervosa.

Browse Anorexia Nervosa studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 to physical activity

Criteria specific to constitutionally lean women

  • ≤ 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

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Constitutional leanness

    Constitutional leanness

    Behavioral: REST-Fixed · Behavioral: REST-AdLib · Behavioral: EX-AdLib

  • Experimental
    Normal weight

    Normal weight women

    Behavioral: REST-Fixed · Behavioral: REST-AdLib · Behavioral: EX-AdLib

  • Experimental
    Anorexia nevrosa

    women presenting Anorexia nevrosa

    Behavioral: REST-Fixed · Behavioral: REST-AdLib · Behavioral: EX-AdLib

Interventions

  • BehavioralREST-Fixed

    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.

  • BehavioralREST-AdLib

    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.

  • BehavioralEX-AdLib

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: day 1 , day 8

Secondary outcomes

  1. Body fat mass

    the percentage of body fat and the quantity of fat mass will be assessed using X-ray absorptiometry (DXA)

    Time frame: day 1

  2. fat free mass

    the percentage of body fat and the quantity of fat mass will be assessed using X-ray absorptiometry (DXA)

    Time frame: day 1

  3. Physical activity level

    The time spent at low-moderate and vigorous physical activity will be assessed using a 7-day accelerometry record (Actigraph GT3X)

    Time frame: day 1

  4. Daily energy intake

    The amount and quality of food intake will be assessed using a three-day dietary record

    Time frame: Trough 3 days

  5. Food reward

    The participants will be asked to complete a validated computer-based procedure to measure food reward (Leeds Food Preference Questionnaire; LFPQ)

    Time frame: day 1 , day 8 , day 15

  6. 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

    Time frame: day 1 , day 8

  7. 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)

    Time frame: day 1 , day 8 , day 15

07

Study locations

1 site
  • Chu Clermont Ferrand
    Clermont-Ferrand, 63003, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2021 to primary completion in Nov 2023, 30 months.

Of 151 non-industry interventional studies with no phase under Anorexia Nervosa, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 63. This study's 30 months is below that.

Counting every sponsor, half of 151 studies reached it within 43 months; a quarter within 24 and three quarters within 63.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 29, 2019
First posted
Jun 10, 2019
StartActual
Apr 16, 2021
Primary completionActual
Nov 14, 2023
CompletionActual
Nov 14, 2023
Last update
Aug 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03981432
Collaborators
Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
Responsible party
Sponsor
First posted
Jun 10, 2019
Start date
Apr 16, 2021
Primary completion
Nov 14, 2023
Completion
Nov 14, 2023
Last update
Aug 3, 2026

Study contacts

Martine Duclos
principal investigator · University Hospital, Clermont-Ferrand

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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