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临床试验/NCT03981432
NCT03981432已完成不适用

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

University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2021年4月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
试验地点
2
主要终点
Change in energy intake measured during the ad libitum buffet meal (in kcal).

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Common criteria to the three groups
  • 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

排除标准

  • 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.
  • Medication that could interfer with the study.
  • cardiovascular disease or risks
  • Surgery within the last 3 months

研究组 & 干预措施

Constitutional leanness

Experimental

Constitutional leanness

干预措施: REST-Fixed (Behavioral)

Constitutional leanness

Experimental

Constitutional leanness

干预措施: REST-AdLib (Behavioral)

Constitutional leanness

Experimental

Constitutional leanness

干预措施: EX-AdLib (Behavioral)

Normal weight

Experimental

Normal weight women

干预措施: REST-Fixed (Behavioral)

Normal weight

Experimental

Normal weight women

干预措施: REST-AdLib (Behavioral)

Normal weight

Experimental

Normal weight women

干预措施: EX-AdLib (Behavioral)

Anorexia nevrosa

Experimental

women presenting Anorexia nevrosa

干预措施: REST-Fixed (Behavioral)

Anorexia nevrosa

Experimental

women presenting Anorexia nevrosa

干预措施: REST-AdLib (Behavioral)

Anorexia nevrosa

Experimental

women presenting Anorexia nevrosa

干预措施: EX-AdLib (Behavioral)

结局指标

主要结局

Change in energy intake measured during the ad libitum buffet meal (in kcal).

时间窗: 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.

次要结局

  • Physical activity level(day 1)
  • change in energy intake measured during the ad libitum buffet meal (in kcal).(day 1 , day 8)
  • Body fat mass(day 1)
  • fat free mass(day 1)
  • Food reward(day 1 , day 8 , day 15)
  • Hunger feelings(day 1 , day 8 , day 15)
  • Daily energy intake(Trough 3 days)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (2)

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