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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02233283
Acronym
Polynut
Enrollment
9
Registered
2014-09-08
Start date
2014-01-31
Completion date
2015-06-30
Last updated
2015-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female Reproductive System Disorder

Keywords

LH pulsatility, Insulin sensitivity, Metabolism, hypercaloric feeding

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.

Interventions

OTHERClamp

Volunteers will be submitted to hyperinsulinemic, euglycemic clamp studies of 10 hours duration.

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.

OTHERBasal

Keeping the volunteers in the fasting state overnight and for the entire duration of the experiment (10 hours)

Isocaloric diet will conducted for one month, and designed to provide the calculated daily energy needs

Sponsors

Centre Hospitalier Universitaire Vaudois
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 30 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Luteinizing hormone secretionEvery ten minutes for 10 hoursThe 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

MeasureTime frameDescription
Insulin sensitivity10 hoursInsulin sensitivity will be defined as the rate of glucose infusion required to maintain euglycemia during the hyperinsulinemic clamp

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026