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

Not Applicable

• Conditions: Pregnancy Related
• Interventions: Dietary Supplement: FertyBiotic Pregnancy; Other: Control

• Registration Number: NCT04935840
• Lead Sponsor: Fertypharm

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-05-05
• Study First Submitted: 2021-06-07
• Study First Submitted QC: 2021-06-15
• Study First Posted: 2021-06-23
• Status Verified: 2022-06
• Last Update Submitted: 2022-07-26
• Last Update Posted: 2022-07-27
• Primary Completion: 2023-07-23
• Study Completion: 2023-09-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FertyBiotic Pregnancy	FertyBiotic Pregnancy	Participants received FertyBiotic Pregnancy one capsule a day
Control	Control	Participants received 400 mcg of folic acid once a day

Primary Outcome Measures

Name	Time	Method
Glucose homeostasis	30-32 weeks gestation	Glucose homeostasis status will be evaluated by measuring fasting glucose

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital de Sagunto; 🇪🇸 Sagunto, Valencia, Spain