NCT01095614

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 30, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

January 19, 2011

Status Verified

January 1, 2011

Enrollment Period

9 months

First QC Date

February 16, 2010

Last Update Submit

January 18, 2011

Conditions

Substrate Utilization

Keywords

WomenHormonal statusExerciseSubstrate utilizationWomen Hormonal Status (with oral contraception or without any contraception)

Outcome Measures

Primary Outcomes (1)

  • 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

    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)

Secondary Outcomes (1)

  • 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)

Study Arms (2)

12 women with oral contraception

12 women without any contraception

Eligibility Criteria

Age19 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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

You may qualify if:

  • 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.

You may not qualify if:

  • Chronic pathologies : cardiovascular diseases, cancer, chronic inflammation diseases, renal, intestinal impairments
  • Refusal to be registered 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Martine DUCLOS, Pr

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 16, 2010

First Posted

March 30, 2010

Study Start

February 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

January 19, 2011

Record last verified: 2011-01

Locations

FR(1)