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

NCT02416960 | Completed

• 1 other identifier: 11-0326
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Female Infertility; Obesity

Keywords

female infertility; glycemic index; leptin; ghrelin; overweight; obesity; in vitro fertilization

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• 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

Study Arms (3)

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.

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.

Other: Conventional Diet Group

Control Group

NO INTERVENTION

Patients will follow their usual diet for 12 weeks, immediately before the in vitro fertilization cycle.

Interventions

Low Glycemic Index Diet Group OTHER

This diet will be designed as a moderate reduced-energy, moderate-to-high fiber, low glycemic index/load diet.

Low Glycemic Index Diet Group

Conventional Diet Group OTHER

This diet will be designed as a moderate reduced-energy, moderate-to-high fiber, high glycemic index/load diet.

Conventional Diet Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Related Publications (11)

• 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.

  PMID: 15777186 BACKGROUND

• 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.

  PMID: 718832 BACKGROUND

• 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.

  PMID: 19501317 BACKGROUND

• Marfell-Jones, M., Olds, T., Stewart, A., and Carter, J.E.L. 2006. International standards for anthropometric assessment. North-West University, Potchefstroom, RSA.

  BACKGROUND

• 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.

  PMID: 3899825 BACKGROUND

• 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.

  PMID: 18443342 BACKGROUND

• 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.

  PMID: 21537431 BACKGROUND

• 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.

  PMID: 24874777 BACKGROUND

• 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.

  PMID: 11239536 BACKGROUND

• 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.

  PMID: 19828144 BACKGROUND

• 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.

  PMID: 26561614 DERIVED

MeSH Terms

Conditions

Infertility, Female; Obesity; Overweight

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cileide C Moulin, PhD

  UFRGS/HCPA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2015
• First Posted: April 15, 2015
• Study Start: January 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 15, 2015

Record last verified: 2015-04

Locations

BR (1)