Management of Constitutional Thinness Through an Adapted Physical Activity Program, Whether or Not Associated With Food Supplementation. Interventional Study Compared to Matched Controls: NUTRILEAN + Study

Study Overview
=================
Brief Summary
-----------------
The main aim of the present study is to compare the effect of a 12-week physical activity program on body weight gain and body composition changes between normal weight and constitutionally lean individuals. The second objective will be to question the potential additional effect of a protein supplementation coupled to the physical training intervention on body wright and body composition in constitutionally lean women.

Detailed Description
-----------------
After a medical inclusion visit, the participants will realize a maximal aerobic test at the university hospital as well as a body composition analysis, a blood sample will be taken, their resting metabolic rate will be assessed as well as their energy metabolism during a rectangular cycling exercise. Their muscle strength and architecture will be assessed. Their energy intake and eating habits will also be assessed as well as their diet-induced thermogenesis in response to a fixed and an ad libitum meal. Their sleep metabolism will also be assessed using the Dreem technology. Questionnaires will be used to evaluate their daily free living energy intake and accelerometers used to assess their daily physical activity level. The participants will then perform a 12-week physical activity intervention with 15 of the 30 constitutionally lean one receiving a protein supplementation (randomly assigned). All the measures will be replicated at the end of the intervention as well as 6 weeks after

Official Title
-----------------
Management of Constitutional Thinness Through an Adapted Physical Activity Program, Whether or Not Associated With Food Supplementation. Interventional Study Compared to Matched Controls: NUTRILEAN + Study

Conditions
-----------------
Healthy Normal Weight Women, Constitutionally Lean Women

Intervention / Treatment
-----------------
* Behavioral: Physical training alone
* Behavioral: physical training + protein intake


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion criteria common to both groups Adult women aged 18 to 35, having a stable weight for at least 3 months. Body mass index (BMI) ≤ 17.5 kg / m2 (for the constitutional thinness group) or 20 kg / m2 ≤ BMI ≤ 25 kg / m2 (for the normal-weighted control group) Able to give informed consent to participate in research. Affiliation to a Social Security scheme. Inclusion criteria specific to women with constitutional thinness BMI ≤ 17.5 kg / m2 Weight stable for at least 3 months No eating disorder No biological markers of undernutrition Absence of secondary amenorrhea Inclusion criteria specific to normo-weighted subjects 20 kg / m2 ≤ BMI ≤ 25 kg / m2 Weight stable for at least 3 months No eating disorder No biological markers of undernutrition Absence of secondary amenorrhea Exclusion Criteria: Pregnant or breastfeeding woman Severe progressive disease Medical or surgical history judged by the investigator to be incompatible with this study Diabetes or any other pathology limiting the application of one or the other trial strategy History of cardiovascular and / or neuro-vascular pathology, and / or cardiovascular and / or neuro-vascular risk factors (excluding obesity / overweight) Surgical intervention in the previous 3 months Taking medications that may interfere with the results of the study Regular practice of intense physical activity (more than 3 physical activity sessions per week) Regular consumption of tobacco or alcohol Special diet Abnormal plasma levels of IGF-1, estradiol, free T3, cortisol and leptin (only for the constitutional thinness group) Persons under guardianship or subjects deprived of their liberty by judicial or administrative decision Person in a period of exclusion from another study Refusal of participation

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

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Normal weight<br>the normal weight women will receive the 12-week physical activity intervention and serve as a control group. | Behavioral: Physical training alone<br>* The physical activity intervention will consist in 12 weeks of training composed of 3 sessions per week. The three sessions will be mainly composed of resistance training aiming at increasing body weight through increased fat free mass. The main muscle groups (lower limbs, upper limbs and trunk) will be trained. The intervention will be performed under the supervision of a specialized coach.<br>|
| Experimental: constitutionally lean women - Physical training only<br>women will receive the 12-week physical activity intervention | Behavioral: Physical training alone<br>* The physical activity intervention will consist in 12 weeks of training composed of 3 sessions per week. The three sessions will be mainly composed of resistance training aiming at increasing body weight through increased fat free mass. The main muscle groups (lower limbs, upper limbs and trunk) will be trained. The intervention will be performed under the supervision of a specialized coach.<br>|
| Experimental: constitutionally lean women - Physical training + proteins<br>women will receive the 12-week physical activity intervention in addition to a protein supplementation | Behavioral: physical training + protein intake<br>* The physical activity intervention will consist in 12 weeks of training composed of 3 sessions per week. The three sessions will be mainly composed of resistance training aiming at increasing body weight through increased fat free mass. The main muscle groups (lower limbs, upper limbs and trunk) will be trained. The intervention will be performed under the supervision of a specialized coach. 15 women with constitutional leanness will, on top of the physical training, received a daily protein supplementation corresponding to 20 grams of proteins + 10 grams of Maltodextrine<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight from baseline | body weight using a classical scale at different time : baseline, after the 12-week intervention and after 6 weeks of follow-up . | day 1, day 90, day 145 | 
| Change in fat mass composition | fat mass will be assessed using DXA | day 1, day 90, day 145 | 
| Change in fat free mass composition | fat free mass will be assessed using DXA | day 1, day 90, day 145 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bone structure | the bone structure will be assessed thanks to DXA and pQCT | day 1, day 90, day 145 | 
| Change in muscle strength | muscle strength assessed thanks to isometric contraction using Biodex. | day 1, day 90, day 145 | 
| Change in muscle structure | muscle structure assessed thanks to muscle echography | day 1, day 90, day 145 | 
| Change in aerobic capacities . | aerobic capacities assessed using indirect calorimetry during a graded cycling exercise | day 1, day 90, day 145 | 
| Change in resting metabolic rate | resting metabolic rate assessed using indirect calorimetry during 30 minute rest in a comfortable inclined chair. The is the energy expended at rest in Kilo-Joules. | day 1, day 90, day 145 | 
| Change in Insulin | Insulin will be evaluated in blood sample | day 1, day 90, day 145 | 
| Change in glycaemia, . | glycaemia will be evaluated in blood sample | day 1, day 90, day 145 | 
| Change in triglycerides | triglycerides will be evaluated in blood sample | day 1, day 90, day 145 | 
| Change in cholesterol | cholesterol will be evaluated in blood sample | day 1, day 90, day 145 | 
| Change in leptin | leptin will be evaluated in blood sample | day 1, day 90, day 145 | 
| Change in ghrelin | ghrelin will be evaluated in blood sample | day 1, day 90, day 145 | 
| Change in adiponectin | adiponectin will be evaluated in blood sample | day 1, day 90, day 145 | 
| Change in thyroid hormones | thyroid hormones will be evaluated in blood sample | day 1, day 90, day 145 | 
| Change in LipoxMax | the point of maximal use of lipids during exercise will be assessed during a graded exercise composed of 4 stages of 6 minutes each, using indirect calorimetry. | day 1, day 90, day 145 | 
| Change in Energy intake | Energy Intake will be assessed using a Three-day dietary report (self-reported) | day 1, day 90, day 145 | 
| Change in physical activity level measured with an accelerometer | The time spent at low-moderate and vigorous physical activity will be assessed using a 7-day accelerometry record | day 1, day 90, day 145 | 
| Change in sleep metabolism assessed with the dreem technology captors | sleep metabolism assessed during a complete night, using the Dreem technology captors that consists in a simple band around the head during the night. | day 1, day 90, day 145 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
energy metabolism, body composition, physical training, constitutional leanness