Energy Intake, Exercise and Constitutional Leanness

Study Overview
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Brief Summary
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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
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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.

Official Title
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Identification of the Physical and Dietary Profile on Constitutionally Lean People: the NUTRILEAN Study

Conditions
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Anorexia Nervosa, Constitutional Leanness

Intervention / Treatment
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* Behavioral: REST-Fixed
* Behavioral: REST-AdLib
* Behavioral: EX-AdLib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: all participants receive the same intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Constitutional leanness<br>Constitutional leanness | Behavioral: REST-Fixed<br>* 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.<br>Behavioral: REST-AdLib<br>* 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.<br>Behavioral: EX-AdLib<br>* 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.<br>|
| Experimental: Normal weight<br>Normal weight women | Behavioral: REST-Fixed<br>* 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.<br>Behavioral: REST-AdLib<br>* 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.<br>Behavioral: EX-AdLib<br>* 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.<br>|
| Experimental: Anorexia nevrosa<br>women presenting Anorexia nevrosa | Behavioral: REST-Fixed<br>* 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.<br>Behavioral: REST-AdLib<br>* 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.<br>Behavioral: EX-AdLib<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | day 1 , day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body fat mass | the percentage of body fat and the quantity of fat mass will be assessed using X-ray absorptiometry (DXA) | day 1 | 
| fat free mass | the percentage of body fat and the quantity of fat mass will be assessed using X-ray absorptiometry (DXA) | 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) | day 1 | 
| Daily energy intake | The amount and quality of food intake will be assessed using a three-day dietary record | 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) | 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 | 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) | day 1 , day 8 , day 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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appetite control, leanness, physical fitness