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临床试验/NCT05319704
NCT05319704Unknown不适用

Specificities of the Eccentric Exercise: Energy Expenditure and Nature of Oxidized Substrates

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2021年2月17日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
12
试验地点
1
主要终点
Measures of oxidation rate of lipid substrates at T2 visit and T3 visit

研究概览

简要总结

Main objective of this clinical trial is to compare the oxidation rates of main carbohydrate and lipid substrates during exercises carried out in eccentric dynamic pedaling mode on a cycloergometer compared to concentric exercises (classic pedaling) at the same oxygen consumption (VO2).

The hypothesis is that lipid oxidation during an eccentric exercise is higher than lipid oxidation during a concentric exercise, done in humans at the capacity of 30% of VO2max.

详细描述

The written agreement of the subjects will be obtained after information on the aims, nature and possible risks of the study.

Before inclusion, the volunteers will be subjected to a medical check-up at the Nutritional Exploration Unit which includes an examination of personal and family history and current drug treatments, as well as a standard medical examination and a blood test for a biological check-up. Also, the volunteers will be subjected to a check-up with dietetics. Compliance with the inclusion/ exclusion criteria will be verified during this review. Volunteers included in the protocol will go to the Sports Medicine service, or the Nutritional Exploration Unit, or the Clinical Pharmacology Center (CPC) to perform the 11 interventions.

The study will be conducted in 6 periods:

T0 : A standard maximal exercices test performed on an cycloergometer to determine the subject's abilities (VO2) and to set the target powers of the experimental clinical tests. This test will take place in the Sports Medicine service.

T1 : A period of habituation to eccentric exercise, starting from 6 sessions of habituation realized over a period of 15 days where the sessions are gradually increased in duration and intensity. This test will take place in the Sports Medicine service. Before each session of habituation, a Visual Analogue Scale (VAS) will be performed. If the result will be greater than or equal to 3, the session will be rescheduled for another session after 48 hours.

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
20 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Male volunteers between 20 and 40 years old (20 ≥ years ≤ 40)
  • Subjects considered healthy by investigator based on the examination, medical and clinical examination
  • Body Mass Index between 27 and 35 kg/m² (27 < BMI < 35)
  • Biological check up considered compatible with study participation
  • Physical check up considered compatible with study participation (no bones, articular or muscular problems)
  • Person who don't smoke and has no treatment
  • Person who is in the position to sign informed consent

排除标准

  • Person who take any kind of treatments except Paracétamol
  • All conditions who have interaction with this clinical trial, or who can deteriorate the exercise capacity or the realization of canopy (claustrophobia)
  • Administrative and legal factors
  • Person who isn't consent
  • Subject not affiliated with social security
  • Subject during the exclusion period of a previous study (after verification in the Biomedical Research Volunteers File).

结局指标

主要结局

Measures of oxidation rate of lipid substrates at T2 visit and T3 visit

时间窗: Through effort test

The oxidation rate of lipid substrates is measured at 10% of VO2max, 20% of VO2max, 40% of VO2max and 50% of VO2max

次要结局

  • Measure of total energy expenditure at T2 visit and T3 visit(through recovery after exercise, an average of 1 hour)
  • Measure of energy expenditure during 6 hours of recovery after exercises(6 hours)
  • Measures of substrates oxidation rates at T4 visit and T5 visit(through effort test)
  • Measures of quantities of oxidized substrates at T4 visit and T5 visit(through effort test)
  • Measures of oxidation rate of carbohydrates at T2 visit and T3 visit(Through effort test)
  • Measures of quantities of fats at T4 visit and T5 visit(Through energy expenditure measurment an average of 6 hours)
  • Measure of total energy expenditure(30 min)
  • Measures of quantities of carbohydrates at T4 visit and T5 visit(Through energy expenditure measurment an average of 6 hours)

研究者

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

研究点 (1)

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