Energy Intake, Exercise and Constitutional Leanness

NCT03981432 | Completed

• 1 other identifier: RBHP 2018 DUCLOS 3
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Conditions

Anorexia Nervosa; Constitutional Leanness

Keywords

appetite control; leanness; physical fitness

Outcome Measures

Primary Outcomes (1)

• 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.

  day 1 , day 8

Secondary Outcomes (7)

• Body fat mass

  day 1

• fat free mass

  day 1

• Physical activity level

  day 1

• Daily energy intake

  Trough 3 days

• Food reward

  day 1 , day 8 , day 15

Study Arms (3)

Constitutional leanness

EXPERIMENTAL

Constitutional leanness

Behavioral: REST-Fixed; Behavioral: REST-AdLib; Behavioral: EX-AdLib

Normal weight

EXPERIMENTAL

Normal weight women

Behavioral: REST-Fixed; Behavioral: REST-AdLib; Behavioral: EX-AdLib

Anorexia nevrosa

EXPERIMENTAL

women presenting Anorexia nevrosa

Behavioral: REST-Fixed; Behavioral: REST-AdLib; Behavioral: EX-AdLib

Interventions

REST-Fixed BEHAVIORAL

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.

Anorexia nevrosa; Constitutional leanness; Normal weight

REST-AdLib BEHAVIORAL

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.

Anorexia nevrosa; Constitutional leanness; Normal weight

EX-AdLib BEHAVIORAL

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.

Anorexia nevrosa; Constitutional leanness; Normal weight

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques: collaborator

Study Sites (1)

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Anorexia Nervosa; Thinness

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Martine Duclos

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: all participants receive the same intervention

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: June 10, 2019
• Study Start: April 16, 2021
• Primary Completion: November 14, 2023
• Study Completion: November 14, 2023
• Last Updated: February 9, 2024

Record last verified: 2024-02

Locations

FR (1)