Clinical trial NCT02233283: Effect of Modifications of Nutritional Intake Upon Reproductive Hormones in Normal Women
Official title: Effect of Metabolic Variations Upon the Activity of the Neuroendocrine Reproductive Axis in Normal Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female Reproductive System Disorder
Keywords: LH pulsatility
Insulin sensitivity
Metabolism
hypercaloric feeding
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2014-09-08
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Undernutrition has a known and well recognized negative impact on reproductive hormones, and ultimately fertility. In contrast, much less is known regarding the potential effects of overnutrition on the same hormones. Epidemiological data suggest that overnutrition might have a deleterious impact as well on the fertile potential of affected women, but very little is known about the mechanisms implicated. Such knowledge may be of importance, given the increasing prevalence of overweight and obesity worldwide.

Detailed description: In the present study, the investigators will perform a very detailed study of the minute to minute regulation of hormones of the neuroendocrine reproductive axis in normal young female volunteers. These studies will initially be performed at base line during isocaloric diet, where the stimulation of LH secretion by exogenous insulin will be tested during hyperinsulinemic eugylcemic clamp studies.

The same studies will then be repeated after a period of one month of controlled hypercaloric diet, where volunteers will receive an excess of approximately 30% KCal compared to their calculated daily energy expenditure. it is anticipated that such hypercaloric nutrition will induce a significant decrease in normal insulin sensitivity of these volunteers. Thus, the effect of changing whole body insulin sensitivity on the fine regulation of neuroendocrine reproductive hormones will be evaluated.

Eligibility criteria: Inclusion Criteria:

normally cycling young (between 18 and 30 yo) female, with a BMI between 20 and 25 kg/m2.

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Exclusion Criteria:

* Personal history of endocrine dysfunction (any kind)
* Hormonal contraception
* Pregnancy
* Food allergy (any kind)
* Intense physical activity (\>4 hrs/week)
* Smoking

Primary outcomes:
measure: Luteinizing hormone secretion
timeFrame: Every ten minutes for 10 hours
Secondary outcomes:
measure: Insulin sensitivity
timeFrame: 10 hours
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Clinical Research Center, University Hospital
state: Vaud
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois
name: Francois P Pralong, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Leckwyck M, Kong W, Burton KJ, Amati F, Vionnet N, Pralong FP. Decreasing Insulin Sensitivity in Women Induces Alterations in LH Pulsatility. J Clin Endocrinol Metab. 2016 Aug;101(8):3240-9. doi: 10.1210/jc.2016-1727. Epub 2016 Jun 16.