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Completed

NCT Number: NCT03981432

Energy Intake, Exercise and Constitutional Leanness

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

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

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

Registry information

Official study title

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

Acronym: Nutrilean

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 10, 2019
Registry last updated
Feb 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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