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

NCT ID: NCT02233283

Last Updated: 2015-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-06-30

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.

Conditions

Female Reproductive System Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Hypercaloric diet and basal

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

Group Type: ACTIVE_COMPARATOR

Hypercaloric diet

Intervention Type: 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.

Basal

Intervention Type: OTHER

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

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

Group Type: EXPERIMENTAL

Clamp

Intervention Type: OTHER

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

Hypercaloric diet

Intervention Type: 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.

Isocaloric diet and basal

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

Group Type: ACTIVE_COMPARATOR

Basal

Intervention Type: OTHER

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

Isocaloric diet

Intervention Type: OTHER

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

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

Group Type: EXPERIMENTAL

Clamp

Intervention Type: OTHER

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

Isocaloric diet

Intervention Type: OTHER

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

Interventions

Clamp

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

Intervention Type: 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.

Intervention Type: OTHER

Basal

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

Intervention Type: OTHER

Isocaloric diet

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

Intervention Type: OTHER

Other Intervention Names

Hyperinsulinemic and euglycemic clamp study; Overfeeding; Fasting; Controlled diet

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: lead

Responsible Party

Francois Pralong

Full professor and Head, Service of Endocrinology, Diabetology and Metabolism

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francois P Pralong, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Vaudois

Locations

Clinical Research Center, University Hospital

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

References

van Leckwyck M, Kong W, Burton KJ, Amati F, Vionnet N, Pralong FP. Decreasing Insulin Sensitivity in Women Induces Alterations in LH Pulsatility. J Clin Endocrinol Metab. 2016 Aug;101(8):3240-9. doi: 10.1210/jc.2016-1727. Epub 2016 Jun 16.

Reference Type: DERIVED

PMID: 27309039 (View on PubMed)

Other Identifiers

320030_141065

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

43/13

Identifier Type: -

Identifier Source: org_study_id