Substrate Utilization and Hormonal Status in Women

NCT ID: NCT01095614

Last Updated: 2011-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Substrate Utilization

Study Groups

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12 women with oral contraception

No interventions assigned to this group

12 women without any contraception

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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French Federation of Physical Education and Gymnastic (EPGV)

UNKNOWN

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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CHU Clermont-Ferrand

Principal Investigators

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Martine DUCLOS, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Countries

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France

Other Identifiers

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AU818

Identifier Type: OTHER

Identifier Source: secondary_id

CHU-0068

Identifier Type: -

Identifier Source: org_study_id

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