Pregnancy Related
Conditions
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.
Interventions
DIETARY_SUPPLEMENTFertyBiotic Pregnancy
DHA, folic acid, Iodine, iron, Lactobacillus rhamnosus, Lactobacillus reuterii, magnesium, zinc, vitamin D3, Vitamin C, Vitamin E, Group B vitamins and Biotin
OTHERControl
400 mcg of folic acid
Sponsors
Fertypharm
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose homeostasis | 30-32 weeks gestation | Glucose homeostasis status will be evaluated by measuring fasting glucose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin levels | 30-32 weeks gestation | Insulin levels status will be evaluated by measuring fasting insulin |
| Insulin resistance | 30-32 weeks gestation | Insulin resistance will be evaluated by measuring HOMA IR and QUICKI index (fasting glucose and fasting insulin combination) |
| Weight gain | 30-32 weeks gestation | Weight will be evaluated weighting the subjects |
| Lipid concentration | 30-32 weeks gestation | Lipid concentration will be evaluated by measuring fasting total colesterol, LDL, HDL and triglyceride |
Countries
Spain
Outcome results
None listed