Clinical trial NCT01095614: Substrate Utilization and Hormonal Status in Women
Official title: Impact of Women Hormonal Status (Oral Contraception vs no Contraception) on Substrate Utilization During Exercise
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Substrate Utilization
Keywords: Women
Hormonal status
Exercise
Substrate utilization
Women Hormonal Status (with oral contraception or without any contraception)
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: French Federation of Physical Education and Gymnastic (EPGV)
First posted: 2010-03-30
Enrollment: 24
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Sampling method: PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: during exercise (between 12h and 12h45)
Secondary outcomes:
measure: 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
timeFrame: before (8h, 8h45), during (12h, 12h20, 12h30, 12h45) and after exercise (13h15, 13h45; 14h45)
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Martine DUCLOS, Pr
role: PRINCIPAL_INVESTIGATOR
References: