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Energy Intake, Exercise and Constitutional Leanness

Identification of the Physical and Dietary Profile on Constitutionally Lean People: the NUTRILEAN Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03981432
Acronym
Nutrilean
Enrollment
34
Registered
2019-06-10
Start date
2021-04-16
Completion date
2023-11-14
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia Nervosa, Constitutional Leanness

Keywords

appetite control, leanness, physical fitness

Brief 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

Detailed description

Body composition (using X-ray absorptiometry), muscle strength (biodex), daily energy intake (dietary record), food preferences (Leeds Food Preference Questionnaire) and physical activity level (GT3X accelerometers) will be assessed among women with constitutional leanness normal weight women and women with anorexia nervosa. The CT and NW groups will then be asked to randomly realized three experimental session: i) a rest session with an fixed lunch meal; a rest session with an ad libitum meal ; iii) an exercise session with an ad libitum meal. Their ad libitum energy intake will be assessed during the two last sessions. Appetite feelings will be assessed at regular intervals and their food reward in response to the lunch will also be assessed.

Interventions

BEHAVIORALREST-Fixed

condition without exercise / rest condition. The participants will be asked to remain quiet and at rest during the morning and will receive a fixed meal at lunch. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.

BEHAVIORALREST-AdLib

condition without exercise / rest condition. The participants will be asked to remain quiet and at rest during the morning and will receive an ad libitum meal at lunch. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.

BEHAVIORALEX-AdLib

condition with an acute exercise set 30 minutes before the lunch meal that will be served ad libitum This will be a 30-minute exercise set at 65% of their capacities (cycling), 30 minutes before lunch.

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER
Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

all participants receive the same intervention

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in energy intake measured during the ad libitum buffet meal (in kcal).day 1 , day 8food intake will be measured ad libitum during a lunch buffet. The participants will be offered an ad libitum buffet-type meal composed based on their food intake preferences. Their intake will be weighted using an electronic food scale by a member of the investigation team and then analysed using Bilnuts software.

Secondary

MeasureTime frameDescription
Body fat massday 1the percentage of body fat and the quantity of fat mass will be assessed using X-ray absorptiometry (DXA)
fat free massday 1the percentage of body fat and the quantity of fat mass will be assessed using X-ray absorptiometry (DXA)
Physical activity levelday 1The time spent at low-moderate and vigorous physical activity will be assessed using a 7-day accelerometry record (Actigraph GT3X)
Daily energy intakeTrough 3 daysThe amount and quality of food intake will be assessed using a three-day dietary record
Food rewardday 1 , day 8 , day 15The participants will be asked to complete a validated computer-based procedure to measure food reward (Leeds Food Preference Questionnaire; LFPQ)
change in energy intake measured during the ad libitum buffet meal (in kcal).day 1 , day 8food intake will be measured ad libitum during a lunch buffet. The participants will be offered an ad libitum buffet-type meal composed based on their food intake preferences. Their intake will be weighted using an electronic food scale by a member of the investigation team and then analysed using Bilnuts software
Hunger feelingsday 1 , day 8 , day 15hunger area under the curve will be assessed using visual analogue scale through a the day using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation)

Countries

France

Contacts

PRINCIPAL_INVESTIGATORMartine Duclos

University Hospital, Clermont-Ferrand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 4, 2026