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
- Constitutionally Lean WomenHealthy Normal Weight Women
- Interventions
- Behavioral: Physical training aloneBehavioral: physical training + protein intake
- Registration Number
- NCT04749706
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 45
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description constitutionally lean women - Physical training only Physical training alone women will receive the 12-week physical activity intervention constitutionally lean women - Physical training + proteins physical training + protein intake women will receive the 12-week physical activity intervention in addition to a protein supplementation Normal weight Physical training alone the normal weight women will receive the 12-week physical activity intervention and serve as a control group.
- Primary Outcome Measures
Name Time Method Change in body weight from baseline day 1, day 90, day 145 body weight using a classical scale at different time : baseline, after the 12-week intervention and after 6 weeks of follow-up .
Change in fat free mass composition day 1, day 90, day 145 fat free mass will be assessed using DXA
Change in fat mass composition day 1, day 90, day 145 fat mass will be assessed using DXA
- Secondary Outcome Measures
Name Time Method Change in LipoxMax day 1, day 90, day 145 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.
Change in sleep metabolism assessed with the dreem technology captors day 1, day 90, day 145 sleep metabolism assessed during a complete night, using the Dreem technology captors that consists in a simple band around the head during the night.
Change in muscle structure day 1, day 90, day 145 muscle structure assessed thanks to muscle echography
Change in triglycerides day 1, day 90, day 145 triglycerides will be evaluated in blood sample
Change in bone structure day 1, day 90, day 145 the bone structure will be assessed thanks to DXA and pQCT
Change in resting metabolic rate day 1, day 90, day 145 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.
Change in muscle strength day 1, day 90, day 145 muscle strength assessed thanks to isometric contraction using Biodex.
Change in cholesterol day 1, day 90, day 145 cholesterol will be evaluated in blood sample
Change in ghrelin day 1, day 90, day 145 ghrelin will be evaluated in blood sample
Change in adiponectin day 1, day 90, day 145 adiponectin will be evaluated in blood sample
Change in thyroid hormones day 1, day 90, day 145 thyroid hormones will be evaluated in blood sample
Change in Energy intake day 1, day 90, day 145 Energy Intake will be assessed using a Three-day dietary report (self-reported)
Change in physical activity level measured with an accelerometer day 1, day 90, day 145 The time spent at low-moderate and vigorous physical activity will be assessed using a 7-day accelerometry record
Change in aerobic capacities . day 1, day 90, day 145 aerobic capacities assessed using indirect calorimetry during a graded cycling exercise
Change in Insulin day 1, day 90, day 145 Insulin will be evaluated in blood sample
Change in glycaemia, . day 1, day 90, day 145 glycaemia will be evaluated in blood sample
Change in leptin day 1, day 90, day 145 leptin will be evaluated in blood sample
Trial Locations
- Locations (1)
Chu Clermont Ferrand
🇫🇷Clermont-Ferrand, France