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Substrate Utilization and Hormonal Status in Women

2011年1月18日 更新者：University Hospital, Clermont-Ferrand

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

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.

研究概览

地位

完全的

条件

详细说明

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.

研究类型

观察性的

注册 (预期的)

24

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 法国
      • Clermont-Ferrand、法国、63003
        • CHU clermont-ferrand

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

19年 至 30年 (成人)

接受健康志愿者

是的

有资格学习的性别

女性

取样方法

概率样本

研究人群

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

描述

Inclusion Criteria:

  • Female
  • 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.

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

队列和干预

团体/队列
12 women with oral contraception
12 women without any contraception

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
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
大体时间：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.
during exercise (between 12h and 12h45)

次要结果测量

结果测量
措施说明
大体时间
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
大体时间：before (8h, 8h45), during (12h, 12h20, 12h30, 12h45) and after exercise (13h15, 13h45; 14h45)

The hormonal regulations involved in the substrate utilization will be assessed thanks to blood samples collected before, during and after exercise.

At each blood collection, the nurses will collect a EDTA tube (5ml) used to assess free fatty acid and glycerol; and 2 heparin ones (2*5ml) to assess 17β-œstradiol, progesterone, triglycerides, cholesterol, HDL-C, LDL-C, glucose, insulin, growth hormone, IGF-I, IGFBP-1, IGFBP-3, adrenaline, noradrenaline, Atrial Natriuretic Peptide, and C-Reactive Protein.
before (8h, 8h45), during (12h, 12h20, 12h30, 12h45) and after exercise (13h15, 13h45; 14h45)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University Hospital, Clermont-Ferrand

合作者

French Federation of Physical Education and Gymnastic (EPGV)

调查人员

  • 首席研究员：Martine DUCLOS, Pr、University Hospital, Clermont-Ferrand

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年2月1日

初级完成 (实际的)

2010年11月1日

研究完成 (实际的)

2010年11月1日

研究注册日期

首次提交

2010年2月16日

首先提交符合 QC 标准的

2010年3月29日

首次发布 (估计)

2010年3月30日

研究记录更新

最后更新发布 (估计)

2011年1月19日

上次提交的符合 QC 标准的更新

2011年1月18日

最后验证

2011年1月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • CHU-0068
  • AU818 (其他标识符：CPP)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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