Status:
UNKNOWN
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
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Healthy Normal Weight Women
Constitutionally Lean Women
Eligibility:
FEMALE
18-35 years
Phase:
NA
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 indiv...
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 met...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 11 2023
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04749706
Start Date
May 1 2021
End Date
December 11 2023
Last Update
May 3 2021
Active Locations (1)
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1
Chu Clermont Ferrand
Clermont-Ferrand, France, 63003