Probiotic Supplementation in Obese Pregnant Women. A Feasibility Study.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Childhood Obesity
- Sponsor
- Arkansas Children's Hospital Research Institute
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in acceptance of probiotic supplementation throughout pregnancy in obese women.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This study will assess the feasibility of a randomized control trial in which the effects of probiotic supplementation throughout pregnancy on maternal insulin sensitivity and inflammation, as well offspring gene expression and body composition are examined.
Detailed Description
Maternal obesity leads to increased insulin resistance and inflammation which have been shown to induce fetal adaptations and greater risk of obesity in the offspring. Probiotic supplementation during pregnancy has been shown to improve insulin sensitivity in normal weight women. However, little is known on the effects of probiotic supplementation throughout pregnancy on maternal insulin sensitivity and inflammation as well as offspring gene expression and body composition. Long term nutritional supplementation, however, is associated with increased participant burden as well as lower compliance and retention rates. Thus, this study will assess the feasibility of a long term probiotic supplementation study in obese pregnant women. Acceptance and compliance with daily capsules throughout pregnancy and study procedures will be assessed.
Investigators
Eligibility Criteria
Inclusion Criteria
- •≥ 18 years of age
- •Singleton pregnancy
- •Less than 12 weeks of gestation
- •Less than 1 serving of yoghurt with live cultures or cultured milk per week
- •Conceived without assisted fertility treatments
Exclusion Criteria
- •• Women with pre-existing medical conditions (e.g., diabetes, hypertension, thyroid disorders, heart disease or immune disorders) as determined by the PI to affect the outcomes of interest
- •Immunosuppressed women
- •Women taking medications during pregnancy known to affect fetal growth (i.e., thyroid hormone, glucocorticoids, insulin, oral hypoglycemic agents)
- •Women who are using recreational drugs, tobacco or alcohol during their pregnancy
- •Milk intolerance or allergy
- •Consuming probiotic supplements
Outcomes
Primary Outcomes
Change in acceptance of probiotic supplementation throughout pregnancy in obese women.
Time Frame: Self-administered questionnaires will be done at gestation weeks 12,14, 18, 22, 26, 30 and 36
Participants will answer acceptability questionnaires in which they will have to rate (1= poor, 2= fair, 3= good, 4= very good, and 5= excellent ) their experience with capsule supplementation and study procedures.
Change in compliance with probiotic supplementation throughout pregnancy in obese women.
Time Frame: Pill count will be done at gestation weeks 12,14, 18, 22, 26, 30 and 36
Change in compliance with capsule supplementation will be assessed during pregnancy via pill-count.