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Energy Intake, Exercise and Constitutional Leanness (Nutrilean)

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ClinicalTrials.gov Identifier: NCT03981432
Recruitment Status : Not yet recruiting
First Posted : June 10, 2019
Last Update Posted : June 10, 2019
Sponsor:
Collaborator:
Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Constitutional Leanness Behavioral: REST-Fixed Behavioral: REST-AdLib Behavioral: EX-AdLib Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: all participants receive the same intervention
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Identification of the Physical and Dietary Profile on Constitutionally Lean People: the NUTRILEAN Study
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Constitutional leanness
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. Daily energy intake [ Time Frame: Trough 3 days ]
    The amount and quality of food intake will be assessed using a three-day dietary record

  5. 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)

  6. 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

  7. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03981432


Contacts
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Contact: Lise Laclautre 334.73.754.963 promo_interne_drci@chu-clermontferrand.fr

Locations
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France
Chu Clermont Ferrand Not yet recruiting
Clermont-Ferrand, France, 63003
Contact: Lise Laclautre       promo_interne_drci@chu-clermontferrand.fr   
Principal Investigator: Martine DUCLOS         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
Investigators
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Principal Investigator: Martine Duclos University Hospital, Clermont-Ferrand

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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03981432     History of Changes
Other Study ID Numbers: RBHP 2018 DUCLOS 3
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
appetite control
leanness
physical fitness
Additional relevant MeSH terms:
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Anorexia
Thinness
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders
Body Weight