- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03981432
Energy Intake, Exercise and Constitutional Leanness (Nutrilean)
February 8, 2024 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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
34
Phase
- 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
-
-
-
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
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 |
Intervention / Treatment |
---|---|
Experimental: Constitutional leanness
|
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.
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.
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
|
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.
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.
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
|
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.
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.
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
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
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.
Collaborators
Investigators
- 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)
April 16, 2021
Primary Completion (Actual)
November 14, 2023
Study Completion (Actual)
November 14, 2023
Study Registration Dates
First Submitted
April 29, 2019
First Submitted That Met QC Criteria
June 7, 2019
First Posted (Actual)
June 10, 2019
Study Record Updates
Last Update Posted (Estimated)
February 9, 2024
Last Update Submitted That Met QC Criteria
February 8, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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