Effect of Modifications of Nutritional Intake Upon Reproductive Hormones in Normal Women (Polynut)

Vaud University Hospital Center

Status: Completed

Conditions: Female Reproductive System Disorder

Treatments: Other: Clamp; Other: Basal; Other: Hypercaloric diet; Other: Isocaloric diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02233283

43/13

320030_141065 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: Female

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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9 participants in 4 patient groups

Hypercaloric diet and basal

Active Comparator group

Description:

Volunteers fed a hypercaloric diet for one month will be submitted to a fasting period of ten hours duration

Treatment:

Other: Hypercaloric diet

Other: Basal

Hypercaloric diet and clamp

Experimental group

Description:

Volunteers fed a hypercaloric diet for one month will be submitted to a hyperinsulinemic and euglycemic clamp of ten hours duration

Treatment:

Other: Hypercaloric diet

Other: Clamp

Isocaloric diet and basal

Active Comparator group

Description:

Volunteers fed a isocaloric diet for one month will be submitted to a fasting period of ten hours duration

Treatment:

Other: Isocaloric diet

Other: Basal

Isocaloric diet and clamp

Experimental group

Description:

Volunteers fed a isocaloric diet for one month will be submitted to a hyperinsulinemic and euglycemic clamp of ten hours duration

Treatment:

Other: Isocaloric diet

Other: Clamp