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

August 20, 2015 updated by: Francois Pralong, Centre Hospitalier Universitaire Vaudois

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • Clinical Research Center, University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hypercaloric diet and basal
Volunteers fed a hypercaloric diet for one month will be submitted to a fasting period of ten hours duration
Other: 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.
Other Names:
  • Overfeeding
Other: Basal
Keeping the volunteers in the fasting state overnight and for the entire duration of the experiment (10 hours)
Other Names:
  • Fasting
Experimental: Hypercaloric diet and clamp
Volunteers fed a hypercaloric diet for one month will be submitted to a hyperinsulinemic and euglycemic clamp of ten hours duration
Other: 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.
Other Names:
  • Overfeeding
Other: Clamp
Volunteers will be submitted to hyperinsulinemic, euglycemic clamp studies of 10 hours duration.
Other Names:
  • Hyperinsulinemic and euglycemic clamp study
Active Comparator: Isocaloric diet and basal
Volunteers fed a isocaloric diet for one month will be submitted to a fasting period of ten hours duration
Other: Basal
Keeping the volunteers in the fasting state overnight and for the entire duration of the experiment (10 hours)
Other Names:
  • Fasting
Other: Isocaloric diet
Isocaloric diet will conducted for one month, and designed to provide the calculated daily energy needs
Other Names:
  • Controlled diet
Experimental: Isocaloric diet and clamp
Volunteers fed a isocaloric diet for one month will be submitted to a hyperinsulinemic and euglycemic clamp of ten hours duration
Other: Clamp
Volunteers will be submitted to hyperinsulinemic, euglycemic clamp studies of 10 hours duration.
Other Names:
  • Hyperinsulinemic and euglycemic clamp study
Other: Isocaloric diet
Isocaloric diet will conducted for one month, and designed to provide the calculated daily energy needs
Other Names:
  • Controlled diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Every ten minutes for 10 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Vaudois

Investigators

  • Principal Investigator: Francois P Pralong, MD, Centre Hospitalier Universitaire Vaudois

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

July 21, 2014

First Submitted That Met QC Criteria

September 2, 2014

First Posted (Estimate)

September 8, 2014

Study Record Updates

Last Update Posted (Estimate)

August 21, 2015

Last Update Submitted That Met QC Criteria

August 20, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 43/13
  • 320030_141065 (Other Grant/Funding Number: Swiss National Science Foundation)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Female Reproductive System Disorder

Clinical Trials on Hypercaloric diet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe