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临床试验/NCT01095614
NCT01095614已完成不适用

Impact of Women Hormonal Status (Oral Contraception vs no Contraception) on Substrate Utilization During Exercise

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2010年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
Substrate utilization will be the main outcome under study.For each volunteer, it will be assessed during exercise (between 12h and 12h45) for the 2 experimental conditions with exercise

研究概览

简要总结

Women sexual hormones (i.e. estrogen) are involved in the regulation of substrate utilization and storage. Being under oral contraception (OC) may conduct to metabolic and hormonal modifications, but results are confused regarding the impact on substrate utilization. In the present study, the aim is then to explore the effect of hormonal status on substrate utilization during sous-maximal exercise, comparing women with and without OC.

We hypothesised that women under OC have a lower Respiratory Exchange Ratio (RER) at exercise than women without contraception underlying a greater reliance on fat oxidation.

详细描述

24 healthy young women (12 with OC and 12 without any contraception) will complete a maximal test on an ergometer cycle to obtain their maximal oxygen consumption (VO2max).Their body composition will be assessed by DXA. They will be asked to complete 3 experimental sessions.

During a first session the volunteers will remain inactive, and only a breakfast will be offered. During the second session, a breakfast will be offered and they will have to complete a sub-maximal exercise set at 60% of their VO2max 3 hours after breakfast. And the third session will consist in the realisation of exercise on fast state. Those three sessions will be realized in a randomized order. Several blood (catheter) and salivary samples will be collected during the three sessions, throughout the experimental day.

研究设计

研究类型
Observational

入排标准

年龄范围
19 Years 至 30 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Adults between 19 to 30 years old
  • Body mass index between 20 and 25 kg.m-²
  • Oral contraception (half of the sample) : mini-dosed, and mono-phasic, ethinyl estradiol ≤ 30 µg
  • Without contraception (half of the sample)
  • Affiliated to National Health Insurance
  • Subject giving her written informed consent
  • Subject considered as normal after clinical examination and medical questionnaire.

排除标准

  • Chronic pathologies : cardiovascular diseases, cancer, chronic inflammation diseases, renal, intestinal impairments
  • Refusal to be registered on the National Volunteers Data file
  • Being in exclusion on the National Volunteers Data file
  • Practising intensive physical exercise
  • Heavy consumer of alcohol or/and tobacco
  • Previous medical and/or surgery judged by the investigator as incompatible with this study
  • Pregnancy

结局指标

主要结局

Substrate utilization will be the main outcome under study.For each volunteer, it will be assessed during exercise (between 12h and 12h45) for the 2 experimental conditions with exercise

时间窗: during exercise (between 12h and 12h45)

Substrate utilization: The Respiratory Exchange Ratio (RER) that corresponds to carbon dioxide production divided by oxygen consumption (VCO2/VO2) will be used to determine the energetic substrate used during exercise. This RER will be obtained, in continuous, thanks to an indirect calorimetric system composed of a breath by breath gas analyzer. A RER closed to 0.7 illustrates lipid utilization while carbohydrate use will correspond to a RER that reached 1.

次要结局

  • The hormonal regulation involved in substrate utilization. It will be assessed during the 3 experimental conditions during all the experimental day: - Breakfast + exercise - Exercise alone - Breakfast alone(before (8h, 8h45), during (12h, 12h20, 12h30, 12h45) and after exercise (13h15, 13h45; 14h45))

研究者

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

研究点 (1)

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