Female InfertilityNCT02416960

Effect of the Glycemic Index of Diet on Metabolic and Reproductive Parameters in Overweight and Obese Infertile Women

A study testing Low Glycemic Index Diet Group and Conventional Diet Group in people with Female Infertility and Obesity, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 35 years, women only
Conditions the study is for: Female Infertility, Obesity
What is being tested?: Low Glycemic Index Diet Group and Conventional Diet Group
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 1 siteBrazil
Study dates: Jan 2012to Dec 2013
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 35 years
Women only
No healthy volunteers
Adult

Who may be able to join

Diagnose of female infertility and indication for treatment with in vitro fertilization
Body Mass Index (BMI) equal or greater than 30 kg/m² or BMI > 25 kg/m² with increased waist circumference (> 80 cm);
Being not treated (diet) for weight loss/gain and maintaining stable body weight in the three months prior to the study;
Not having stomach/digestive problems
Not having the knowledge of cardiovascular disease history;
Non-smokers;
Not using any medication.

Who cannot join

Patients with BMI equal or higher than 40 kg/m² (morbid obesity)
Patients who are already receiving some type of nutritional intervention
Patients with co-morbidities that may interfere with reproductive capacity (genetic and/or endocrine disorders, diabetes mellitus, cancer, liver or kidney failure), alcoholics, individuals who have contact (work) with heavy metals or chemicals (exposure to solvents and pesticides)
Lack of adherence to the proposed dietary treatment

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul

Other trials in Brazil

About this study

Official title: Effect of a Hypocaloric Diet With Different Glycemic Indexes on Ghrelin and Leptin Levels, Metabolic Parameters, and Reproductive Outcomes in Overweight and Obese Infertile Women: A Randomized Clinical Trial

Read the detailed description

Infertility has been currently recognized as a disorder related to obesity. Among several metabolic changes associated with obesity, insulin resistance appears to be linked to hormonal disorders that affect reproductive system. Leptin and ghrelin are hormones involved in energy balance regulation and are also associated with reproductive system regulation, but its relationship with infertility is scarce. The aim of this study is to determine the effect of a hypocaloric diet with different glycemic indexes on ghrelin and leptin levels, hormonal, metabolic and reproductive parameters in infertile overweight or obese women candidates to in vitro fertilization. Infertile women with grade I and II obesity, or pre-obesity with increased waist circumference will be recruited. Patients will be assigned to Hypocaloric Low Glycemic Index diet group; Hypocaloric Conventional diet group or Control group (maintenance of usual diet), and will follow the protocol for 12 weeks. The two intervention diets will be similar in terms of caloric intake and macronutrient distribution and different in terms of carbohydrates quality (index and glycemic load). Immediately after the end of the diet protocol, the patients will be submitted to the in vitro fertilization treatment. Before and after the intervention anthropometric measurements (weight, height, body mass index, waist and hip circumference) and body composition (body fat percentage determined by the measurement of seven skinfolds) will be evaluated as well as biochemical parameters: leptin, acylated ghrelin, glucose, insulin, serum lipids (total cholesterol and lipoproteins, and triglycerides), sex hormones - follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol, progesterone, prolactin, testosterone and sex hormone binding globulin (SHBG). Primary outcome: clinical pregnancy rate. Secondary outcomes: HOMA-IR (Homeostasis Model Assessment), acylated ghrelin and leptin levels, body fat percentage, number of oocytes retrieved, percentage of fertilized oocytes and embryo quality.

Conditions: Female Infertility, Obesity
Being tested: Low Glycemic Index Diet Group, Conventional Diet Group
Keywords: female infertility, glycemic index, leptin, ghrelin, overweight, obesity, in vitro fertilization
Medical subject headings: Infertility, Female, Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Low Glycemic Index Diet GroupOther
This diet will be designed as a moderate reduced-energy, moderate-to-high ﬁber, low glycemic index/load diet.
Conventional Diet GroupOther
This diet will be designed as a moderate reduced-energy, moderate-to-high ﬁber, high glycemic index/load diet.

Study groups in NCT02416960
Study group	Role	What they receive
Low Glycemic Index Diet Group	Experimental	Patients will follow a treatment with a hypocaloric diet with low glycemic index/load for 12 weeks, immediately before the in vitro fertilization cycle. Receives: Other: Low Glycemic Index Diet Group
Conventional Diet Group	Active comparator	Patients will follow a treatment with a hypocaloric diet with high glycemic index/load for 12 weeks, immediately before the in vitro fertilization cycle. Receives: Other: Conventional Diet Group
Control Group	No intervention	Patients will follow their usual diet for 12 weeks, immediately before the in vitro fertilization cycle.

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical Pregnancy Rate
Clinical Pregnancy will be considered as pregnancy diagnosed by ultrasound visualization of one or more gestational sacs or definitive clinical signs of pregnancy.
Measured: up to 18 weeks - in average, two weeks after the end of the in vitro fertilization cycle

Secondary outcomes (7)

HOMA-IR index (Homeostasis Model Assessment)
The HOMA-IR index will be obtained by the following formula: fasting glucose (mg/dl/18) x fasting insulin (U/mL)/22.5.
Measured: baseline and 12 weeks
Acylated Ghrelin Levels (pg/dL)
The levels of acylated ghrelin will be determined by enzyme immunoassay (SPI BIO, Montigny le Bretonneux, France) using a plate reader (Biochrom Anthos MultiRead 400, Biochrom Ltd., Cambridge, UK).
Measured: baseline and 12 weeks
Leptin Levels (ng/mL)
The levels of leptin will be determined by enzyme immunoassay (SPI BIO, Montigny le Bretonneux, France) using a plate reader (Biochrom Anthos MultiRead 400, Biochrom Ltd., Cambridge, UK).
Measured: baseline and 12 weeks
Body Fat Percentage (%)
The body fat percentage will be determined measuring the skinfolds at seven sites (triceps, subscapular, suprailiac, axillary, pectoral, abdomen and thigh) using a standardized technique of measurement and determination.
Measured: baseline and 12 weeks
Number of Oocytes Retrieved
Women will follow a pre-established protocol of ovarian stimulation as part of the preparation for the in vitro fertilization cycle. The evolution of oocytes development will be accompanied by the medical team using the ultrasound technique and when at least one oocyte reach the average size of 17 mm the puncture of oocytes by aspiration will be held.
Measured: between 12 and 16 weeks, during the in vitro fertilization cycle
Percentage of Fertilized Oocytes (%)
The percentage of fertilized oocytes will be obtained using the following formula: number of embryos/ total number of oocytes x 100.
Measured: between 12 and 16 weeks, during the in vitro fertilization cycle
Embryo Quality
Embryo quality will be determined by the Embryonic Score Calculation - ESC, where embryos with score 4, are considered the best quality.
Measured: between 12 and 16 weeks, during the in vitro fertilization cycle

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012Dec 2013

First posted15 Apr 2015 (estimated)
Study startJan 2012
Primary completionDec 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Female InfertilityStudies of the same condition, open and under way.
More trials run by Hospital de Clinicas de Porto AlegreThe 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: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02416960
Sponsor's protocol ID: 11-0326
Status last verified: Apr 2015
First submitted: 7 Apr 2015
Last updated: 15 Apr 2015
Results posted: No
Data monitoring committee: No

Publications

Cummings DE, Foster-Schubert KE, Overduin J. Ghrelin and energy balance: focus on current controversies. Curr Drug Targets. 2005 Mar;6(2):153-69. doi: 10.2174/1389450053174569.
PubMed 15777186
Jackson AS, Pollock ML. Generalized equations for predicting body density of men. Br J Nutr. 1978 Nov;40(3):497-504. doi: 10.1079/bjn19780152.
PubMed 718832
Loret de Mola JR. Obesity and its relationship to infertility in men and women. Obstet Gynecol Clin North Am. 2009 Jun;36(2):333-46, ix. doi: 10.1016/j.ogc.2009.03.002.
PubMed 19501317
Marfell-Jones, M., Olds, T., Stewart, A., and Carter, J.E.L. 2006. International standards for anthropometric assessment. North-West University, Potchefstroom, RSA.
Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985 Jul;28(7):412-9. doi: 10.1007/BF00280883.
PubMed 3899825
Metwally M, Ledger WL, Li TC. Reproductive endocrinology and clinical aspects of obesity in women. Ann N Y Acad Sci. 2008 Apr;1127:140-6. doi: 10.1196/annals.1434.000.
PubMed 18443342
Singla P, Bardoloi A, Parkash AA. Metabolic effects of obesity: A review. World J Diabetes. 2010 Jul 15;1(3):76-88. doi: 10.4239/wjd.v1.i3.76.
PubMed 21537431
Sliwowska JH, Fergani C, Gawalek M, Skowronska B, Fichna P, Lehman MN. Insulin: its role in the central control of reproduction. Physiol Behav. 2014 Jun 22;133:197-206. doi: 10.1016/j.physbeh.2014.05.021. Epub 2014 May 27.
PubMed 24874777
Terriou P, Sapin C, Giorgetti C, Hans E, Spach JL, Roulier R. Embryo score is a better predictor of pregnancy than the number of transferred embryos or female age. Fertil Steril. 2001 Mar;75(3):525-31. doi: 10.1016/s0015-0282(00)01741-6.
PubMed 11239536
Zegers-Hochschild F, Adamson GD, de Mouzon J, Ishihara O, Mansour R, Nygren K, Sullivan E, Vanderpoel S; International Committee for Monitoring Assisted Reproductive Technology; World Health Organization. International Committee for Monitoring Assisted Reproductive Technology (ICMART) and the World Health Organization (WHO) revised glossary of ART terminology, 2009. Fertil Steril. 2009 Nov;92(5):1520-4. doi: 10.1016/j.fertnstert.2009.09.009. Epub 2009 Oct 14.
PubMed 19828144
Becker GF, Passos EP, Moulin CC. Short-term effects of a hypocaloric diet with low glycemic index and low glycemic load on body adiposity, metabolic variables, ghrelin, leptin, and pregnancy rate in overweight and obese infertile women: a randomized controlled trial. Am J Clin Nutr. 2015 Dec;102(6):1365-72. doi: 10.3945/ajcn.115.117200. Epub 2015 Nov 11.
PubMed 26561614

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Female Infertility trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of a Hypocaloric Diet With Different Glycemic Indexes on Ghrelin and Leptin Levels, Metabolic Parameters, and Reproductive Outcomes in Overweight and Obese Infertile Women: A Randomized Clinical Trial
ClinicalTrials.gov ID: NCT02416960
Acronym / sponsor ID: 11-0326
Conditions: Female Infertility, Obesity
Keywords: female infertility, glycemic index, leptin, ghrelin, overweight, obesity, in vitro fertilization
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Hospital de Clinicas de Porto AlegreUniversity, hospital or other
Collaborators: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
Study start: Jan 2012
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 15 Apr 2015 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Low Glycemic Index Diet Group	Experimental	Other: Low Glycemic Index Diet GroupPatients will follow a treatment with a hypocaloric diet with low glycemic index/load for 12 weeks, immediately before the in vitro fertilization cycle.
Conventional Diet Group	Active comparator	Other: Conventional Diet GroupPatients will follow a treatment with a hypocaloric diet with high glycemic index/load for 12 weeks, immediately before the in vitro fertilization cycle.
Control Group	No intervention	–Patients will follow their usual diet for 12 weeks, immediately before the in vitro fertilization cycle.

Who may qualify

Ages: 18 to 35 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Diagnose of female infertility and indication for treatment with in vitro fertilization
Body Mass Index (BMI) equal or greater than 30 kg/m² or BMI > 25 kg/m² with increased waist circumference (> 80 cm);
Being not treated (diet) for weight loss/gain and maintaining stable body weight in the three months prior to the study;
Not having stomach/digestive problems
Not having the knowledge of cardiovascular disease history;

Key exclusion criteria (4 listed)

Patients with BMI equal or higher than 40 kg/m² (morbid obesity)
Patients who are already receiving some type of nutritional intervention
Patients with co-morbidities that may interfere with reproductive capacity (genetic and/or endocrine disorders, diabetes mellitus, cancer, liver or kidney failure), alcoholics, individuals who have contact (work) with heavy metals or chemicals (exposure to solvents and pesticides)
Lack of adherence to the proposed dietary treatment

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
Low Glycemic Index Diet GroupThis diet will be designed as a moderate reduced-energy, moderate-to-high ﬁber, low glycemic index/load diet.	Other	Low Glycemic Index Diet Group
Conventional Diet GroupThis diet will be designed as a moderate reduced-energy, moderate-to-high ﬁber, high glycemic index/load diet.	Other	Conventional Diet Group

Primary outcome

Clinical Pregnancy Rate
Time frame: up to 18 weeks - in average, two weeks after the end of the in vitro fertilization cycle
Clinical Pregnancy will be considered as pregnancy diagnosed by ultrasound visualization of one or more gestational sacs or definitive clinical signs of pregnancy.

7 secondary outcomes

HOMA-IR index (Homeostasis Model Assessment)
Time frame: baseline and 12 weeks
Acylated Ghrelin Levels (pg/dL)
Time frame: baseline and 12 weeks
Leptin Levels (ng/mL)
Time frame: baseline and 12 weeks
Body Fat Percentage (%)
Time frame: baseline and 12 weeks
Number of Oocytes Retrieved
Time frame: between 12 and 16 weeks, during the in vitro fertilization cycle
Percentage of Fertilized Oocytes (%)
Time frame: between 12 and 16 weeks, during the in vitro fertilization cycle
Embryo Quality
Time frame: between 12 and 16 weeks, during the in vitro fertilization cycle

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 15 Apr 2015.
Background: PubMed 15777186Cummings DE, Foster-Schubert KE, Overduin J. Ghrelin and energy balance: focus on current controversies. Curr Drug Targets. 2005 Mar;6(2):153-69. doi: 10.2174/1389450053174569.
Background: PubMed 718832Jackson AS, Pollock ML. Generalized equations for predicting body density of men. Br J Nutr. 1978 Nov;40(3):497-504. doi: 10.1079/bjn19780152.
Background: PubMed 19501317Loret de Mola JR. Obesity and its relationship to infertility in men and women. Obstet Gynecol Clin North Am. 2009 Jun;36(2):333-46, ix. doi: 10.1016/j.ogc.2009.03.002.
BackgroundMarfell-Jones, M., Olds, T., Stewart, A., and Carter, J.E.L. 2006. International standards for anthropometric assessment. North-West University, Potchefstroom, RSA.
Background: PubMed 3899825Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985 Jul;28(7):412-9. doi: 10.1007/BF00280883.
Background: PubMed 18443342Metwally M, Ledger WL, Li TC. Reproductive endocrinology and clinical aspects of obesity in women. Ann N Y Acad Sci. 2008 Apr;1127:140-6. doi: 10.1196/annals.1434.000.
Background: PubMed 21537431Singla P, Bardoloi A, Parkash AA. Metabolic effects of obesity: A review. World J Diabetes. 2010 Jul 15;1(3):76-88. doi: 10.4239/wjd.v1.i3.76.
Background: PubMed 24874777Sliwowska JH, Fergani C, Gawalek M, Skowronska B, Fichna P, Lehman MN. Insulin: its role in the central control of reproduction. Physiol Behav. 2014 Jun 22;133:197-206. doi: 10.1016/j.physbeh.2014.05.021. Epub 2014 May 27.
Background: PubMed 11239536Terriou P, Sapin C, Giorgetti C, Hans E, Spach JL, Roulier R. Embryo score is a better predictor of pregnancy than the number of transferred embryos or female age. Fertil Steril. 2001 Mar;75(3):525-31. doi: 10.1016/s0015-0282(00)01741-6.
Background: PubMed 19828144Zegers-Hochschild F, Adamson GD, de Mouzon J, Ishihara O, Mansour R, Nygren K, Sullivan E, Vanderpoel S; International Committee for Monitoring Assisted Reproductive Technology; World Health Organization. International Committee for Monitoring Assisted Reproductive Technology (ICMART) and the World Health Organization (WHO) revised glossary of ART terminology, 2009. Fertil Steril. 2009 Nov;92(5):1520-4. doi: 10.1016/j.fertnstert.2009.09.009. Epub 2009 Oct 14.
Derived from this study: PubMed 26561614Becker GF, Passos EP, Moulin CC. Short-term effects of a hypocaloric diet with low glycemic index and low glycemic load on body adiposity, metabolic variables, ghrelin, leptin, and pregnancy rate in overweight and obese infertile women: a randomized controlled trial. Am J Clin Nutr. 2015 Dec;102(6):1365-72. doi: 10.3945/ajcn.115.117200. Epub 2015 Nov 11.

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RecruitingPhase 2
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
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PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
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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.

Cileide C Moulin, PhD principal investigator

UFRGS/HCPA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Low Glycemic Index Diet Group and Conventional Diet Group in people with Female Infertility and Obesity, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.

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 7 inclusion and 4 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 15 Apr 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 Brazil. 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?

Clinical Pregnancy Rate (time frame: up to 18 weeks - in average, two weeks after the end of the in vitro fertilization cycle). 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 NCT02416960, which also lists 11 linked publications.

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 15 Apr 2015.