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

Female Reproductive System Disorder Clinical Trial

— Polynut  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02233283
• Other study ID #: 43/13
• Secondary ID: 320030_141065
• Status: Completed
• Phase: N/A
• First received: July 21, 2014
• Last updated: August 20, 2015
• Start date: January 2014
• Est. completion date: June 2015

Study information

• Verified date: August 2015
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Personal history of endocrine dysfunction (any kind)

• Hormonal contraception

• Pregnancy

• Food allergy (any kind)

• Intense physical activity (>4 hrs/week)

• Smoking

Study Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Female Reproductive System Disorder

Intervention

Other:
• Clamp
Volunteers will be submitted to hyperinsulinemic, euglycemic clamp studies of 10 hours duration.
• 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.
• Basal
Keeping the volunteers in the fasting state overnight and for the entire duration of the experiment (10 hours)
• Isocaloric diet
Isocaloric diet will conducted for one month, and designed to provide the calculated daily energy needs

Locations

Country	Name	City	State
Switzerland	Clinical Research Center, University Hospital	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Luteinizing hormone secretion	The pulsatility of LH will be assessed by measuring LH levels in blood sample obtained every ten minutes over the entire study period (12 hours).	Every ten minutes for 10 hours	No
Secondary	Insulin sensitivity	Insulin sensitivity will be defined as the rate of glucose infusion required to maintain euglycemia during the hyperinsulinemic clamp	10 hours	No