Clinical trial NCT03981432: Energy Intake, Exercise and Constitutional Leanness
Official title: Identification of the Physical and Dietary Profile on Constitutionally Lean People: the NUTRILEAN Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia Nervosa
Constitutional Leanness
Keywords: appetite control
leanness
physical fitness
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
First posted: 2019-06-10
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: all participants receive the same intervention
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: 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 contraindication to physical activity

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

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

Primary outcomes:
measure: Change in energy intake measured during the ad libitum buffet meal (in kcal).
timeFrame: day 1 , day 8
Secondary outcomes:
measure: Body fat mass
timeFrame: day 1
measure: fat free mass
timeFrame: day 1
measure: Physical activity level
timeFrame: day 1
measure: Daily energy intake
timeFrame: Trough 3 days
measure: Food reward
timeFrame: day 1 , day 8 , day 15
measure: change in energy intake measured during the ad libitum buffet meal (in kcal).
timeFrame: day 1 , day 8
measure: Hunger feelings
timeFrame: day 1 , day 8 , day 15
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Chu Clermont Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Martine Duclos
role: PRINCIPAL_INVESTIGATOR
References: