Energy Intake, Exercise and Constitutional Leanness

NCT ID: NCT03981432

Last Updated: 2024-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-16

Study Completion Date

2023-11-14

Brief Summary

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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

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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.

Conditions

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Anorexia Nervosa Constitutional Leanness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

all participants receive the same intervention
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Constitutional leanness

Constitutional leanness

Group Type EXPERIMENTAL

REST-Fixed

Intervention Type 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.

REST-AdLib

Intervention Type 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.

EX-AdLib

Intervention Type 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.

Normal weight

Normal weight women

Group Type EXPERIMENTAL

REST-Fixed

Intervention Type 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.

REST-AdLib

Intervention Type 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.

EX-AdLib

Intervention Type 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

women presenting Anorexia nevrosa

Group Type EXPERIMENTAL

REST-Fixed

Intervention Type 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.

REST-AdLib

Intervention Type 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.

EX-AdLib

Intervention Type 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.

Interventions

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REST-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.

Intervention Type BEHAVIORAL

REST-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.

Intervention Type BEHAVIORAL

EX-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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques

OTHER

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martine Duclos

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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Chu Clermont Ferrand

Clermont-Ferrand, , France

Site Status

Countries

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France

Other Identifiers

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RBHP 2018 DUCLOS 3

Identifier Type: -

Identifier Source: org_study_id

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