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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04935840
• Other study ID #: 2020_FBE_04
• Status: Recruiting
• Phase: N/A
• Start date: May 5, 2021
• Est. completion date: September 23, 2023

Study information

• Verified date: June 2022
• Source: Fertypharm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: September 23, 2023
• Est. primary completion date: July 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Dietary Supplement:
• FertyBiotic Pregnancy
DHA, folic acid, Iodine, iron, Lactobacillus rhamnosus, Lactobacillus reuterii, magnesium, zinc, vitamin D3, Vitamin C, Vitamin E, Group B vitamins and Biotin

Other:
• Control
400 mcg of folic acid

Locations

Country	Name	City	State
Spain	Hospital de Sagunto	Sagunto	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Fertypharm

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose homeostasis	Glucose homeostasis status will be evaluated by measuring fasting glucose	30-32 weeks gestation
Secondary	Insulin levels	Insulin levels status will be evaluated by measuring fasting insulin	30-32 weeks gestation
Secondary	Insulin resistance	Insulin resistance will be evaluated by measuring HOMA IR and QUICKI index (fasting glucose and fasting insulin combination)	30-32 weeks gestation
Secondary	Weight gain	Weight will be evaluated weighting the subjects	30-32 weeks gestation
Secondary	Lipid concentration	Lipid concentration will be evaluated by measuring fasting total colesterol, LDL, HDL and triglyceride	30-32 weeks gestation