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Clinical Trials/NCT03981432
NCT03981432
Completed
Not Applicable

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

University Hospital, Clermont-Ferrand1 site in 1 country34 target enrollmentApril 16, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anorexia Nervosa
Sponsor
University Hospital, Clermont-Ferrand
Enrollment
34
Locations
1
Primary Endpoint
Change in energy intake measured during the ad libitum buffet meal (in kcal).
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 16, 2021
End Date
November 14, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
University Hospital, Clermont-Ferrand
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Common criteria to the three groups
  • 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

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.
  • Medication that could interfer with the study.
  • cardiovascular disease or risks
  • Surgery within the last 3 months

Outcomes

Primary Outcomes

Change in energy intake measured during the ad libitum buffet meal (in kcal).

Time Frame: day 1 , day 8

food 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 Outcomes

  • Physical activity level(day 1)
  • change in energy intake measured during the ad libitum buffet meal (in kcal).(day 1 , day 8)
  • Body fat mass(day 1)
  • fat free mass(day 1)
  • Food reward(day 1 , day 8 , day 15)
  • Hunger feelings(day 1 , day 8 , day 15)
  • Daily energy intake(Trough 3 days)

Study Sites (1)

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