CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 45 enrolled
Drug / intervention
Low Glycemic Index Diet Group +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02416960
NCT02416960N/ACompleted

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

Hospital de Clinicas de Porto Alegre·interventional·Posted Apr 15, 2015·Updated Apr 15, 2015

In Brief

A clinical study evaluating Low Glycemic Index Diet Group and Conventional Diet Group for Female Infertility and Obesity. Completed, enrolled 45 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 15, 2015
Enrollment StartJan 1, 2012
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 11.2 years ago

Interventions

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.