Clinical Study to Evaluate the Effect of a Food Supplement With Probiotics on the Metabolic Profile of Pregnant Women
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pregnancy Related
- Sponsor
- Fertypharm
- Enrollment
- 84
- Locations
- 2
- Primary Endpoint
- Glucose homeostasis
- Status
- Active, not recruiting
- Last Updated
- 4 months ago
Overview
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 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Glucose homeostasis
Time Frame: 30-32 weeks gestation
Glucose homeostasis status will be evaluated by measuring fasting glucose
Secondary Outcomes
- Insulin levels(30-32 weeks gestation)
- Weight gain(30-32 weeks gestation)
- Insulin resistance(30-32 weeks gestation)
- Lipid concentration(30-32 weeks gestation)