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临床试验/NCT03466359
NCT03466359Unknown不适用

Nutritional Responses to Chronic Exercise- Versus Energy Restriction-induced Energy Deficits in Obese Adolescents

University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年1月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
2
主要终点
Changes in energy intake at lunch time

研究概览

简要总结

The aim of the present study is to compare the effect of two weight loss interventions inducing the same energy deficit but one based on exercise and one using dietary restriction, on appetite control in obese adolescents. Investigator hypothesis that daily energy intake and hunger will be increased in the dietary restriction group but not in response to the exercise program.

详细描述

The present study will compare the nutritional responses to two 4-month weight loss programs inducing the same energy deficit in obese adolescents, one based on exercise and the other one using dietary restriction. After a first 4-month phase stabilizing the adolescents' daily energy intake and expenditure, half of the sample with increase their physical activity to induce a 10% increase of their daily energy expenditure (maintaining the same energy intake) while the other half will stick with the same physical activity program but reduce their daily intake to match for the same 10% energy deficit. Before, at the end and 4 months after the intervention, Investigator will assess the adolescents' energy intake and appetite control by measuring: ad libitum energy intake, appetite feelings throughout the day, food preferences, food reward. But also all the potential underneath mechanisms based on gastro-peptides and adipokines. Finally, sleep metabolism will be assessed using polysomnography as a potential link between weight loss and appetite control. Body composition, quality of life, aerobic capacities and resting metabolic rate will also be measured at each time point.

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
Double (Participant, Care Provider)

入排标准

年龄范围
12 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • BMI percentile > 97th percentile according to the french curves.
  • ages 12-16 years old
  • Signed consent form
  • being registered in the national social security system
  • no contraindication to physical activity

排除标准

  • Previous surgical interventions that is considered as non-compatible with the study.
  • weight loss during the last 6 months
  • cardiovascular disease or risks

研究组 & 干预措施

DEF-EI

Experimental

these adolescents will follow a dietary restriction of 10% of their daily energy intake.

干预措施: DEF-EI : Energy restriction induced energy deficit (Behavioral)

DEF-EX

Experimental

these adolescents will increase their physical activity-induced energy expenditure by 10% per day.

干预措施: DEF-EX : Exercise induced energy deficit (Behavioral)

结局指标

主要结局

Changes in energy intake at lunch time

时间窗: Before, after 10 months and 4 month after the intervention

food intake will be measured ad libitum during a lunch time buffet. The adolescents will be offered an ad libitum buffet-type meal composed based on their food intake preferences. Their intake will be assessed by a member of the investigation team

次要结局

  • change in FM(Before, after 10 months and 4 month after the intervention)
  • Leptin concentration(Before, after 10 months and 4 month after the intervention)
  • appetite feelings(Before, after 10 months and 4 month after the intervention)
  • Quality of life Score(Before, after 10 months and 4 month after the intervention)
  • Health Perception(Before, after 10 months and 4 month after the intervention)
  • Glycaemia concentration(Before, after 10 months and 4 month after the intervention)
  • total cholesterol concentration(Before, after 10 months and 4 month after the intervention.)
  • LDL-C concentration(Before, after 10 months and 4 month after the intervention)
  • Sleep metabolism(Before, after 10 months and 4 month after the intervention)
  • Insulin concentration(Before, after 10 months and 4 month after the intervention)
  • Acylated Ghrelin concentration(Before, after 10 months and 4 month after the intervention)
  • Aerobic capacity(Before, after 10 months and 4 month after the intervention)
  • HDL-C concentration(Before, after 10 months and 4 month after the intervention)
  • Triglycerides concentration(Before, after 10 months and 4 month after the intervention)

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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Energy Intake and Energy Deficit in Obese Adolescents | 临床试验