NCT02233283

Effect of Modifications of Nutritional Intake Upon Reproductive Hormones in Normal Women

Effect of Metabolic Variations Upon the Activity of the Neuroendocrine Reproductive Axis in Normal Female Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Centre Hospitalier Universitaire Vaudois · Academic / Other
• Sex: Female
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

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.

Conditions

• Female Reproductive System Disorder

Interventions

Type	Name	Description
OTHER	Clamp	Volunteers will be submitted to hyperinsulinemic, euglycemic clamp studies of 10 hours duration.
OTHER	Hypercaloric diet	Hypercaloric diet will be conducted during one month, and designed to provide 30% excess in calories compared to daily requirements. It will consist in a high fat, high carbohydrates diet.
OTHER	Basal	Keeping the volunteers in the fasting state overnight and for the entire duration of the experiment (10 hours)
OTHER	Isocaloric diet	Isocaloric diet will conducted for one month, and designed to provide the calculated daily energy needs

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-12-01
• Completion: 2015-06-01
• First posted: 2014-09-08
• Last updated: 2015-08-21

Locations

1 site across 1 country: Switzerland