Substrate Utilization and Hormonal Status in Women

Substrate Utilization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01095614
• Other study ID #: CHU-0068
• Secondary ID: AU818
• Status: Completed
• Phase: N/A
• First received: February 16, 2010
• Last updated: January 18, 2011
• Start date: February 2010
• Est. completion date: November 2010

Study information

• Verified date: January 2011
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 30 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Substrate Utilization

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	French Federation of Physical Education and Gymnastic (EPGV)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	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	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 17ß-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)	Yes