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Energy Intake, Exercise and Constitutional Leanness (Nutrilean)

Primary Purpose

Anorexia Nervosa, Constitutional Leanness

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
REST-Fixed
REST-AdLib
EX-AdLib
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring appetite control, leanness, physical fitness

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Chu Clermont FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Constitutional leanness

Normal weight

Anorexia nevrosa

Arm Description

Constitutional leanness

Normal weight women

women presenting Anorexia nevrosa

Outcomes

Primary Outcome Measures

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

Body fat mass
the percentage of body fat and the quantity of fat mass will be assessed using X-ray absorptiometry (DXA)
fat free mass
the percentage of body fat and the quantity of fat mass will be assessed using X-ray absorptiometry (DXA)
Physical activity level
The time spent at low-moderate and vigorous physical activity will be assessed using a 7-day accelerometry record (Actigraph GT3X)
Daily energy intake
The amount and quality of food intake will be assessed using a three-day dietary record
Food reward
The 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).
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
Hunger feelings
hunger 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)

Full Information

First Posted
April 29, 2019
Last Updated
October 20, 2022
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
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1. Study Identification

Unique Protocol Identification Number
NCT03981432
Brief Title
Energy Intake, Exercise and Constitutional Leanness
Acronym
Nutrilean
Official Title
Identification of the Physical and Dietary Profile on Constitutionally Lean People: the NUTRILEAN Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 16, 2021 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa, Constitutional Leanness
Keywords
appetite control, leanness, physical fitness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
all participants receive the same intervention
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Constitutional leanness
Arm Type
Experimental
Arm Description
Constitutional leanness
Arm Title
Normal weight
Arm Type
Experimental
Arm Description
Normal weight women
Arm Title
Anorexia nevrosa
Arm Type
Experimental
Arm Description
women presenting Anorexia nevrosa
Intervention Type
Behavioral
Intervention Name(s)
REST-Fixed
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
REST-AdLib
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
EX-AdLib
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in energy intake measured during the ad libitum buffet meal (in kcal).
Description
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.
Time Frame
day 1 , day 8
Secondary Outcome Measure Information:
Title
Body fat mass
Description
the percentage of body fat and the quantity of fat mass will be assessed using X-ray absorptiometry (DXA)
Time Frame
day 1
Title
fat free mass
Description
the percentage of body fat and the quantity of fat mass will be assessed using X-ray absorptiometry (DXA)
Time Frame
day 1
Title
Physical activity level
Description
The time spent at low-moderate and vigorous physical activity will be assessed using a 7-day accelerometry record (Actigraph GT3X)
Time Frame
day 1
Title
Daily energy intake
Description
The amount and quality of food intake will be assessed using a three-day dietary record
Time Frame
Trough 3 days
Title
Food reward
Description
The participants will be asked to complete a validated computer-based procedure to measure food reward (Leeds Food Preference Questionnaire; LFPQ)
Time Frame
day 1 , day 8 , day 15
Title
change in energy intake measured during the ad libitum buffet meal (in kcal).
Description
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
Time Frame
day 1 , day 8
Title
Hunger feelings
Description
hunger 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)
Time Frame
day 1 , day 8 , day 15

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise Laclautre
Phone
334.73.754.963
Email
promo_interne_drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martine Duclos
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Clermont Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Martine DUCLOS

12. IPD Sharing Statement

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Energy Intake, Exercise and Constitutional Leanness

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