Evaluation of the Effect of FertyBiotic Pregnancy in the Metabolic Profile in Pregnant Women

Study Overview
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Brief Summary
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The aim of this study is determine the effect of a food supplement with probiotics on metabolic profile and weight gain in pregnant women.

Detailed Description
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After being informed about the study, all patients meeting the inclusion/exclusion criteria and giving written informed consent will be randomized in a double-blind manner in a ratio 1:1 to receive the food supplementation associated with probiotics or placebo (folic acid) once daily.

Official Title
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Clinical Study to Evaluate the Effect of a Food Supplement With Probiotics on the Metabolic Profile of Pregnant Women

Conditions
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Pregnancy Related

Intervention / Treatment
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* Dietary Supplement: FertyBiotic Pregnancy
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women Age: > 35 years old BMI > 25 Women who have signed the informed consent to participate in the study. No intention to change their routine physical activity or usual dietary intakes throughout the study Exclusion Criteria: > 14 weeks' gestation Taking food supplements or probiotics History or current pathology that influence in the study With major fetal abnormalities Had used continuous antibiotic therapy for at least 3 months

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FertyBiotic Pregnancy<br>Participants received FertyBiotic Pregnancy one capsule a day | Dietary Supplement: FertyBiotic Pregnancy<br>* DHA, folic acid, Iodine, iron, Lactobacillus rhamnosus, Lactobacillus reuterii, magnesium, zinc, vitamin D3, Vitamin C, Vitamin E, Group B vitamins and Biotin<br>|
| Placebo Comparator: Control<br>Participants received 400 mcg of folic acid once a day | Other: Control<br>* 400 mcg of folic acid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose homeostasis | Glucose homeostasis status will be evaluated by measuring fasting glucose | 30-32 weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin levels | Insulin levels status will be evaluated by measuring fasting insulin | 30-32 weeks gestation | 
| Insulin resistance | Insulin resistance will be evaluated by measuring HOMA IR and QUICKI index (fasting glucose and fasting insulin combination) | 30-32 weeks gestation | 
| Weight gain | Weight will be evaluated weighting the subjects | 30-32 weeks gestation | 
| Lipid concentration | Lipid concentration will be evaluated by measuring fasting total colesterol, LDL, HDL and triglyceride | 30-32 weeks gestation |