Effect of Modifications of Nutritional Intake Upon Reproductive Hormones in Normal Women
- Conditions
- Female Reproductive System Disorder
- Interventions
- Other: Hypercaloric dietOther: ClampOther: Isocaloric dietOther: Basal
- Registration Number
- NCT02233283
- Lead Sponsor
- Centre Hospitalier Universitaire Vaudois
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 9
normally cycling young (between 18 and 30 yo) female, with a BMI between 20 and 25 kg/m2.
- Personal history of endocrine dysfunction (any kind)
- Hormonal contraception
- Pregnancy
- Food allergy (any kind)
- Intense physical activity (>4 hrs/week)
- Smoking
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Isocaloric diet and basal Isocaloric diet Volunteers fed a isocaloric diet for one month will be submitted to a fasting period of ten hours duration Isocaloric diet and clamp Isocaloric diet Volunteers fed a isocaloric diet for one month will be submitted to a hyperinsulinemic and euglycemic clamp of ten hours duration Hypercaloric diet and basal Hypercaloric diet Volunteers fed a hypercaloric diet for one month will be submitted to a fasting period of ten hours duration Hypercaloric diet and clamp Clamp Volunteers fed a hypercaloric diet for one month will be submitted to a hyperinsulinemic and euglycemic clamp of ten hours duration Hypercaloric diet and basal Basal Volunteers fed a hypercaloric diet for one month will be submitted to a fasting period of ten hours duration Isocaloric diet and clamp Clamp Volunteers fed a isocaloric diet for one month will be submitted to a hyperinsulinemic and euglycemic clamp of ten hours duration Hypercaloric diet and clamp Hypercaloric diet Volunteers fed a hypercaloric diet for one month will be submitted to a hyperinsulinemic and euglycemic clamp of ten hours duration Isocaloric diet and basal Basal Volunteers fed a isocaloric diet for one month will be submitted to a fasting period of ten hours duration
- Primary Outcome Measures
Name Time Method Luteinizing hormone secretion Every ten minutes for 10 hours 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).
- Secondary Outcome Measures
Name Time Method Insulin sensitivity 10 hours Insulin sensitivity will be defined as the rate of glucose infusion required to maintain euglycemia during the hyperinsulinemic clamp
Trial Locations
- Locations (1)
Clinical Research Center, University Hospital
🇨🇭Lausanne, Vaud, Switzerland