NCT Number: NCT06894043
Constitutional Thinness (CT) is a form of stable thinness without malnutrition but with resistance to weight gain, affecting approximately 1% of the general population. The clinical consequences are numerous and the pathophysiology remains poorly understood.
Currently, conventional management involves a high-calorie and frequent diet, combined with the avoidance of endurance physical activity, although there is no significant evidence of its effectiveness.
Our hypothesis is that an adapted physical activity program (APA) combined with compensatory nutrition (CN) could help these patients gain lean mass (muscle mass).
Interested in participating?
Request Info18 year–50 year
Female
Interventional
Not applicable
Saint-Etienne, France, 42055
Location status: Recruiting
Bogdan GALUSCA, PhD
SUB_INVESTIGATOR
David HUPIN, PhD
SUB_INVESTIGATOR
Florence RANCON, Cheffe de projet
CONTACT
(0) 477829458 ext. +33
Leonard FEASSON, PhD
SUB_INVESTIGATOR
Natacha GERMAIN, PhD
CONTACT
(0)477120621 ext. +33
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The APA intervention will consist of a 2-week running-in period, followed by a period of adapted physical activity (APA) for 8 weeks.
The Compensatory Nutrition (NC) intervention will consist of a 2-week running-in period, followed by a period of compensated nutrition (NC) for 8 weeks.
Time frame: From day 1 to week 8
Lean body mass gain (kg) measured by bioimpedance
Time frame: From day 1 to week 8
Body masse index : ratio between weight and height
Time frame: From day 1 to week 8
Ratio between calorie intake and calorie expenditure
Caloric intake measured by dietary records over 2 weeks (calorie); Calorie expenditure: Resting metabolism measured by indirect calorimetry (kcal/24h); + Postprandial thermogenesis measured by indirect calorimetry (kcal/24h);; + Physical activity energy expenditure measured by connected watch (kcal/24h);
Time frame: From day 1 to week 8
Changes in VO2max
Time frame: From day 1 to week 8
SF-12 questionnaire; Self-measurement questionnaire SF-12 (Short Form Health Survey 12); comprising 12 questions assessing 8 dimensions, namely physical functioning, role limitation due to physical problems, role limitation resulting from emotional problems, vitality (energy/fatigue), emotional well-being, social functioning, bodily pain, and perception of general and mental health; each dimension is represented by a score ranging from 0 to 100, with a low score signifying poor health perception in the dimension considered, and a high score signifying the opposite);
Contact information is provided by the study sponsor or research team.
Florence RANCON, Cheffe de projet
CONTACT
(0) 477829458 ext. +33
Natacha GERMAIN, PhD
CONTACT
(0)477120621 ext. +33
Centre Hospitalier Universitaire de Saint Etienne
Other
Acronym: ANIMATION
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