Energy Intake, Exercise and Constitutional Leanness (Nutrilean)

July 31, 2026 updated by: University Hospital, Clermont-Ferrand

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Chu Clermont Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Constitutional leanness
Behavioral: 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.
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.
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.
Experimental: Normal weight
Normal weight women
Behavioral: 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.
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.
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.
Experimental: Anorexia nevrosa
women presenting Anorexia nevrosa
Behavioral: 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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
day 1 , day 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body fat mass
Time Frame: day 1
the percentage of body fat and the quantity of fat mass will be assessed using X-ray absorptiometry (DXA)
day 1
fat free mass
Time Frame: day 1
the percentage of body fat and the quantity of fat mass will be assessed using X-ray absorptiometry (DXA)
day 1
Physical activity level
Time Frame: day 1
The time spent at low-moderate and vigorous physical activity will be assessed using a 7-day accelerometry record (Actigraph GT3X)
day 1
Daily energy intake
Time Frame: Trough 3 days
The amount and quality of food intake will be assessed using a three-day dietary record
Trough 3 days
Food reward
Time Frame: 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)
day 1 , day 8 , day 15
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
day 1 , day 8
Hunger feelings
Time Frame: 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)
day 1 , day 8 , day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Clermont-Ferrand

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Martine DUCLOS, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 16, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 14, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 14, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RBHP 2018 DUCLOS 3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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