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Study aim
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Effect of oral probiotic lactofem on metabolic parameters in overweight pregnant women referred to prenatal clinics of the shiraz hospitals in 2016
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Design
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Effect of oral probiotic capsules Lactofem on metabolic parameters: this research is a double blinded placebo-controlled trial. fasting glucose, lipid profiles, diastolic and systolic blood pressure in pregnant women 18 to 35 years who were overweight and at weeks 16 and 20 of pregnancy on the basis of the questionnaire and randomly selected configuration block design is divided into two groups: placebo and intervention. Each group of 64 people divided into two lactofem capsules daily or placebo until the end of pregnancy. the intervention done at 20 weeks and at the end of 28 weeks and 36 weeks of pregnancy, systolic and diastolic blood pressure and fasting blood samples to assess the lipid profile and glucose, and samples blood sugar 2 hours after breakfast, evaluating.Data evaluation done with placebo and intervention groups then results will be compared with statistical methods.
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Settings and conduct
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This study is an interventional study of double-blind, controlled clinical trial
that studied the effect of lactobacillus probiotic capsule on metabolic parameters of overweight Pregnant women.This research is done in selected hospitals in Shiraz.
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Participants/Inclusion and exclusion criteria
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Pregnant women aged 18 to 35 years and the gestational age of 20 to 24 weeks, with a BMI of over 25, If they have criteria for entering the study, they will be selected.
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Intervention groups
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An interventional study is a double-blind clinical controlled trial in which to study the effect of lactofem probiotic capsule on Metabolic Indicators of Overweight Pregnant Women in two groups, oral probiotic capsule (test) and placebo (control) are checked.
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Main outcome variables
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Comparison of fasting blood sugar level before intervention at 20 weeks,
and after the intervention at weeks 28 and 36 pregnancy in in test and control groups.
Comparison of 2hpp level before intervention at 20 weeks, and after the intervention at weeks 28 and 36 pregnancy in in test and control groups.
Comparison of mean lipid profile before intervention at 20 weeks, and after the intervention at weeks 28 and 36 pregnancy in in test and control groups.
Comparison of systolic and diastolic blood pressure, before intervention at 20 weeks, and after the intervention at weeks 28 and 36 pregnancy in in test and control groups.