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

N/AActive Not RecruitingNCT04935840

Fertypharm84 enrolled

Overview

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

After being informed about the study, all patients meeting the inclusion/exclusion criteria and giving written informed consent all patients will be treated with the food supplement that contain vitamins, minerals and probiotics. All volunteers will receive one capsule per day of the food supplement throughout the study. The duration of the supplementation will be from their inclusion in the study (≤ 14 weeks of gestation) until the 30th-32nd week of pregnancy, the time of the end-of-study visit.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Pregnancy Related

Interventions

FertyBiotic PregnancyDIETARY_SUPPLEMENT

DHA, folic acid, Iodine, iron, Lactobacillus rhamnosus, Lactobacillus reuterii, magnesium, zinc, vitamin D3, Vitamin C, Vitamin E, Group B vitamins and Biotin

ControlOTHER

400 mcg of folic acid

Eligibility

Sex: FEMALEMin age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Pregnant women * Age: \> 18 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

Locations (2)

Hospital Vithas Medimar

Alicante, Alicante, Spain

Centro Ginecologico Dra. García-Pérez Llantada

Zaragoza, Zaragoza, Spain