Female Reproductive System DisorderPolynutNCT02233283
Effect of Modifications of Nutritional Intake Upon Reproductive Hormones in Normal Women
A study testing Clamp, Hypercaloric diet and Basal in people with Female Reproductive System Disorder, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Reproductive System Disorder
- What is being tested?
- Clamp, Hypercaloric diet and Basal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- normally cycling young (between 18 and 30 yo) female, with a BMI between 20 and 25 kg/m2.
- -
Who cannot join
- Personal history of endocrine dysfunction (any kind)
- Hormonal contraception
- Pregnancy
- Food allergy (any kind)
- Intense physical activity (>4 hrs/week)
- Smoking
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinical Research Center, University Hospital
Lausanne, Canton of Vaud, 1011
About this study
Official title: 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.
Read the 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
- Being tested
- Clamp, Hypercaloric diet, Basal, Isocaloric diet
- Keywords
- LH pulsatility, Insulin sensitivity, Metabolism, hypercaloric feeding
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClampOther
Also called Hyperinsulinemic and euglycemic clamp study
Volunteers will be submitted to hyperinsulinemic, euglycemic clamp studies of 10 hours duration.
Hypercaloric dietOther
Also called Overfeeding
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.
BasalOther
Also called Fasting
Keeping the volunteers in the fasting state overnight and for the entire duration of the experiment (10 hours)
Isocaloric dietOther
Also called Controlled diet
Isocaloric diet will conducted for one month, and designed to provide the calculated daily energy needs
| Study group | Role | What they receive |
|---|---|---|
| Hypercaloric diet and basal | Active comparator | Volunteers fed a hypercaloric diet for one month will be submitted to a fasting period of ten hours duration Receives: Other: Hypercaloric diet; Other: Basal |
| Hypercaloric diet and clamp | Experimental | Volunteers fed a hypercaloric diet for one month will be submitted to a hyperinsulinemic and euglycemic clamp of ten hours duration Receives: Other: Clamp; Other: Hypercaloric diet |
| Isocaloric diet and basal | Active comparator | Volunteers fed a isocaloric diet for one month will be submitted to a fasting period of ten hours duration Receives: Other: Basal; Other: Isocaloric diet |
| Isocaloric diet and clamp | Experimental | Volunteers fed a isocaloric diet for one month will be submitted to a hyperinsulinemic and euglycemic clamp of ten hours duration Receives: Other: Clamp; Other: Isocaloric diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Luteinizing hormone secretion
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).
Measured: Every ten minutes for 10 hours
Secondary outcomes (1)
Insulin sensitivity
Insulin sensitivity will be defined as the rate of glucose infusion required to maintain euglycemia during the hyperinsulinemic clamp
Measured: 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Female Reproductive System DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francois Pralong, Centre Hospitalier Universitaire Vaudois
- Investigators
- Francois P Pralong, MD, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233283
- Sponsor's protocol ID
- 43/13
- Other IDs
- 320030_141065
- Acronym
- Polynut
- Status last verified
- Aug 2015
- First submitted
- 21 Jul 2014
- Last updated
- 21 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27309039
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Metabolic Variations Upon the Activity of the Neuroendocrine Reproductive Axis in Normal Female Volunteers
- ClinicalTrials.gov ID
- NCT02233283
- Acronym / sponsor ID
- Polynut / 43/13
- Conditions
- Female Reproductive System Disorder
- Keywords
- LH pulsatility, Insulin sensitivity, Metabolism, hypercaloric feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 8 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hypercaloric diet and basal | Active comparator | Other: Hypercaloric diet, Other: BasalVolunteers fed a hypercaloric diet for one month will be submitted to a fasting period of ten hours duration |
| Hypercaloric diet and clamp | Experimental | Other: Clamp, Other: Hypercaloric dietVolunteers fed a hypercaloric diet for one month will be submitted to a hyperinsulinemic and euglycemic clamp of ten hours duration |
| Isocaloric diet and basal | Active comparator | Other: Basal, Other: Isocaloric dietVolunteers fed a isocaloric diet for one month will be submitted to a fasting period of ten hours duration |
| Isocaloric diet and clamp | Experimental | Other: Clamp, Other: Isocaloric dietVolunteers fed a isocaloric diet for one month will be submitted to a hyperinsulinemic and euglycemic clamp of ten hours duration |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- normally cycling young (between 18 and 30 yo) female, with a BMI between 20 and 25 kg/m2.
- -
Key exclusion criteria (6 listed)
- Personal history of endocrine dysfunction (any kind)
- Hormonal contraception
- Pregnancy
- Food allergy (any kind)
- Intense physical activity (>4 hrs/week)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClampAlso: Hyperinsulinemic and euglycemic clamp studyVolunteers will be submitted to hyperinsulinemic, euglycemic clamp studies of 10 hours duration. | Other | Hypercaloric diet and clamp, Isocaloric diet and clamp |
| Hypercaloric dietAlso: OverfeedingHypercaloric 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 | Hypercaloric diet and basal, Hypercaloric diet and clamp |
| BasalAlso: FastingKeeping the volunteers in the fasting state overnight and for the entire duration of the experiment (10 hours) | Other | Hypercaloric diet and basal, Isocaloric diet and basal |
| Isocaloric dietAlso: Controlled dietIsocaloric diet will conducted for one month, and designed to provide the calculated daily energy needs | Other | Isocaloric diet and basal, Isocaloric diet and clamp |
Primary outcome
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).
1 secondary outcome
Insulin sensitivity
Time frame: 10 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2015.
- Derived from this study: PubMed 27309039van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francois P Pralong, MD principal investigator
Centre Hospitalier Universitaire Vaudois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clamp, Hypercaloric diet and Basal in people with Female Reproductive System Disorder, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Luteinizing hormone secretion (time frame: Every ten minutes for 10 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02233283, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2015.