Childhood Obesity, Inflammation, Insulin Resistance, Maternal Obesity During Childbirth
Conditions
Keywords
Obesity, Inflammation, Pregnancy, Programming
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.
Interventions
DIETARY_SUPPLEMENTProbiotics
Bifidobacterium BB12 and Lactobacillus Rhamosus LGG (50%:50%) capsules.
DIETARY_SUPPLEMENTPlacebo
capsule manufactured to mimic probiotic capsules.
Sponsors
Arkansas Children's Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* BMI ≥ 30 * ≥ 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in acceptance of probiotic supplementation throughout pregnancy in obese women. | 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. | 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. |
Countries
United States
Outcome results
None listed