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
Sponsor study identifier
interventional
45
1 country
1
Study Start
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2013
Actual (reported)Study Completion
December 2013
Actual (reported)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. The patients who meet the inclusion criteria and accept to participate in the study, will be allocated in one of the following groups: Hypocaloric Low Glycemic Index diet group; Hypocaloric Conventional diet group or Control group (maintenance of usual diet) and follow the study protocol for 12 week. Immediately after the end of the diet protocol, the patients will be submitted to the in vitro fertilization treatment.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2013
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
December 2013
Actual (reported)December 2013
Actual (reported)April 7, 2015
Actual (reported)April 15, 2015
Actual (reported)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.
up to 18 weeks - in average, two weeks after the end of the in vitro fertilization cycle
HOMA-IR index (Homeostasis Model Assessment)
baseline and 12 weeks
Acylated Ghrelin Levels (pg/dL)
baseline and 12 weeks
Leptin Levels (ng/mL)
baseline and 12 weeks
Body Fat Percentage (%)
baseline and 12 weeks
Number of Oocytes Retrieved
between 12 and 16 weeks, during the in vitro fertilization cycle
Patients will follow a treatment with a hypocaloric diet with low glycemic index/load for 12 weeks, immediately before the in vitro fertilization cycle.
Patients will follow a treatment with a hypocaloric diet with high glycemic index/load for 12 weeks, immediately before the in vitro fertilization cycle.
Patients will follow their usual diet for 12 weeks, immediately before the in vitro fertilization cycle.
This diet will be designed as a moderate reduced-energy, moderate-to-high fiber, low glycemic index/load diet.
This diet will be designed as a moderate reduced-energy, moderate-to-high fiber, high glycemic index/load diet.
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
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.
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.
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.
Cileide C Moulin, PhD
UFRGS/HCPA
45 participants (actual enrollment reported by the registry).
First Submitted
April 7, 2015
First Posted
April 15, 2015
Study Start
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
Additional Metabolic and Vascular Effects of Exercise in Patients on Diet-based Weight Loss Programs
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
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.
Primary Completion
December 2013
Actual (reported)Study Completion
December 2013
Actual (reported)Last Updated
April 15, 2015
Record last verified: 2015-04
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