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临床试验/NCT05030636
NCT05030636已完成不适用

FIT3 : Exercise Timing for a Novel Treatment for Obesity

Université de Montréal2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2021年9月15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
入组人数
54
试验地点
2
主要终点
Physical activity habits outside the laboratory

研究概览

简要总结

The main objective of this research project is to assess the impact of the timing of exercise on sensory perception, more specifically on taste and smell. Also, the investigators want to identify the optimal exercise timing scenario that maximizes the short-term anorexigenic effect of exercise (i.e. decrease in energy intake at the meal following the exercise session) in each group of teenagers. Hypothesis: exercise immediately before a meal (EX->MEAL) will be the most efficient scenario, and will show a larger impact on males individuals and people who suffer obesity. Subsequently, the investigators want to understand the impacts of exercise on lifestyle habits (i.e. sleep and sedentariness).

For the realization of this research project, the investigators plan to recruit approximately 144 participants, boys and girls with normal weight/obesity, aged 12 to 17 years. Of these participants, half will be male. There are two different exercise timings (i.e. performed at 9:30 am and 11:00 am using a treadmill to test the maximal aerobic capacity) and one sedentary control condition. Participants will take part in 3 experimental visits in a random order (~5 hours/visit at LAPS-UdeM + 24h of real-life monitoring). Appetite sensations, energy intake (i.e. total and macronutrient), activity monitoring using actigraphy, hormonal (i.e. anorexigenic and orexigenic) and chemosensory (i.e. cortical response to taste and smell stimulations) response will be monitored in the laboratory and/or remotely.

This project will measure acute response in laboratory and real-life settings.

详细描述

Obesity before adulthood is associated with increased risk of cardiometabolic disease as well as musculoskeletal and psychosocial complications. Until recently, the two major components of energy balance (i.e. energy expenditure and intake) were thought to act independently on body weight, but a growing body of knowledge in the field of human physiology supports the theory that exercise and nutrition interact (EXiNU). Complementary lifestyle behaviours [e.g. sedentariness and sleep] can also influence energy balance, all acting synergistically on energy balance (EXiNU+). Dr. Mathieu's innovative work recently revealed that the modulation of EX Timing relative to lunch can significantly improve the choice of healthier foods and lower total (-10%) and lipid (-25%) energy intake without further nutritional compensation during the rest of the day.

This unique research project focuses specifically on understanding how EX Timing can regulate energy balance, filling a major gap in the current literature. The strengths and novelty of the current proposal are that: 1) Youth of both sexes and of different body weight status will be investigated; 2) A varied profile of orexigenic and anorexigenic hormones as well as the cortical response to taste and smell will be studied to better understand food choices; 3) Sleep and sedentary behaviours will be evaluated with EX and nutrition to better assess the global influence of EX Timing on energy balance; 4) Cardiometabolic indicators linked to obesity will be monitored.

Primary objective : To identify the optimal EX Timing that maximizes the short-term anorexigenic effect of EX (i.e. decrease in energy intake at the meal following the EX session) in each group of teenagers.

Hypothesis: EX immediately before a meal (EX-->MEAL) will be the most efficient scenario, and will show a larger impact on individuals with obesity and in males.

Secondary objective #1 : To identify the optimal EX Timing that maximizes the medium-term anorexigenic effect of EX (i.e. caloric reduction during the 24 hours following the lunch) in each group of teenagers.

研究设计

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

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Study participants :
  • must be 12-17 years old to ensure proper compliance with the study protocol and similar daily routines (i.e. attend high school);
  • have normal weight or obesity according to World Health Organisation criteria

排除标准

  • Individuals will be excluded if they :
  • follow a specific diet or have food allergies;
  • have an eating disorder (e.g. anorexia or bulimia);
  • have a metabolic disease, are taking supplements or use medication that could influence the study results (e.g. insulin, lipid lowering drugs, corticosteroids);
  • are vegetarian or vegan, who cannot eat our validated meals which contain protein from animal sources;
  • have any intestinal disorders;
  • have physical limitations that restrict them from participating in our EX program;
  • are involved in competitive sports;
  • are not able to read or speak either French or English;
  • currently has COVID-19 or do not agree to respect sanitary measures during the visits; or,
  • smoke or use drugs.

研究组 & 干预措施

EX starts at 9:30 am

Experimental

A warm-up, 30 min at 70% VO2 max and a cool-down performed at 9:30 am.

干预措施: Acute moderate to vigorous exercise performed at a specific moment of the day (Procedure)

EX starts at 11:00 am

Experimental

A warm-up, 30 min at 70% VO2 max and a cool-down performed at 11:00 am.

干预措施: Acute moderate to vigorous exercise performed at a specific moment of the day (Procedure)

No EX

No Intervention

Control condition. A choice of 30 minutes sedentary activities.

结局指标

主要结局

Physical activity habits outside the laboratory

时间窗: 24 hours

Time spent in moderate-to-vigorous intensity.

Energy intake at lunch

时间窗: 30 minutes

Obtained using an ad libitum meal

Eating habits outside the laboratory

时间窗: 24 hours

Ambulatory monitoring of food provided that is eaten (kcal total)

Sedentary activity habits outside the laboratory

时间窗: 24 hours

Time spent in sedentary activities

Sleep activity habits outside the laboratory

时间窗: 24 hours

Time spent sleeping at night

次要结局

  • Circulating concentration of GLP1(Within the 30 minutes devoted to chemosensory testing, prior to the meal at noon, and in the 2 hour period following meal.)
  • Chemosensory response - Taste(Within the 30 minutes devoted to chemosensory testing, prior to the meal at noon.)
  • Circulating levels of ghrelin(Within the 30 minutes devoted to chemosensory testing, prior to the meal at noon, and in the 2 hour period following meal.)
  • Oxytomodulin(Within the 30 minutes devoted to chemosensory testing, prior to the meal at noon, and in the 2 hour period following meal.)
  • Circulating concentration of PYY(Within the 30 minutes devoted to chemosensory testing, prior to the meal at noon.)
  • Chemosensory response - Smell(Within the 30 minutes devoted to chemosensory testing, prior to the meal at noon, and in the 2 hour period following meal.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marie-Ève Mathieu

Marie-Ève Mathieu, Principal investigator

Université de Montréal

研究点 (2)

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