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OpenTrials
Completed

NCT Number: NCT02233283

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

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.

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Key information

Conditions

Female Reproductive System Disorder Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research Center, University Hospital

Lausanne, Canton of Vaud, 1011, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clamp

Other

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

Other names: Hyperinsulinemic and euglycemic clamp study

Hypercaloric diet

Other

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 names: Overfeeding

Basal

Other

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

Other names: Fasting

isocaloric diet

Other

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

Other names: Controlled diet

Primary outcomes

  1. Luteinizing hormone secretion

    Time frame: 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 outcomes

  1. Insulin sensitivity

    Time frame: 10 hours

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Official study title

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

Acronym: Polynut

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Sep 8, 2014
Registry last updated
Aug 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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