Energy Intake, Exercise and Constitutional Leanness (NCT03981432) | Clinical Trial Compass
CompletedNot Applicable
Energy Intake, Exercise and Constitutional Leanness
France34 participantsStarted 2021-04-16
Plain-language summary
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
Who can participate
Age range
18 Years – 35 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study compared people with anorexia nervosa to people who are naturally lean — could you help me understand how my specific diagnosis fits into what this research was actually studying?
2Since this trial has already been completed, would my doctor be able to help me find the published results, and what might those findings about calorie intake during a buffet meal mean for my own treatment plan?
3This study measured how much people ate freely during a single meal — does that kind of research translate into any practical changes in how nutritional treatment for anorexia nervosa is approached?
4Since this was not a treatment trial but more of an observational study, are there actual treatment trials for anorexia nervosa that my doctor thinks would be a better fit for what I need right now?
5Could my doctor explain whether the distinction between anorexia nervosa and constitutional leanness — which this study seemed designed to explore — is something that's relevant to figuring out the right care approach for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in energy intake measured during the ad libitum buffet meal (in kcal).