Energy Intake, Exercise and Constitutional Leanness

Not Applicable

Completed

• Conditions: Constitutional Leanness; Anorexia Nervosa
• Interventions: Behavioral: REST-Fixed; Behavioral: REST-AdLib; Behavioral: EX-AdLib

• Registration Number: NCT03981432
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study First Submitted: 2019-04-29
• Study First Submitted QC: 2019-06-07
• Study First Posted: 2019-06-10
• Study Start: 2021-04-16
• Primary Completion: 2023-11-14
• Study Completion: 2023-11-14
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-08
• Last Update Posted: 2024-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anorexia nevrosa	REST-AdLib	women presenting Anorexia nevrosa
Anorexia nevrosa	REST-Fixed	women presenting Anorexia nevrosa
Anorexia nevrosa	EX-AdLib	women presenting Anorexia nevrosa
Constitutional leanness	REST-Fixed	Constitutional leanness
Constitutional leanness	REST-AdLib	Constitutional leanness
Normal weight	EX-AdLib	Normal weight women
Constitutional leanness	EX-AdLib	Constitutional leanness
Normal weight	REST-AdLib	Normal weight women
Normal weight	REST-Fixed	Normal weight women

Primary Outcome Measures

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

Name	Time	Method
Physical activity level	day 1	The time spent at low-moderate and vigorous physical activity will be assessed using a 7-day accelerometry record (Actigraph GT3X)
change in energy intake measured during the ad libitum buffet meal (in kcal).	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
Body fat mass	day 1	the percentage of body fat and the quantity of fat mass will be assessed using X-ray absorptiometry (DXA)
fat free mass	day 1	the percentage of body fat and the quantity of fat mass will be assessed using X-ray absorptiometry (DXA)
Food reward	day 1 , day 8 , day 15	The participants will be asked to complete a validated computer-based procedure to measure food reward (Leeds Food Preference Questionnaire; LFPQ)
Hunger feelings	day 1 , day 8 , day 15	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)
Daily energy intake	Trough 3 days	The amount and quality of food intake will be assessed using a three-day dietary record

Trial Locations

Locations (1)

Chu Clermont Ferrand; 🇫🇷 Clermont-Ferrand, France