Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72202, United States
NCT Number: NCT03240419
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Little Rock, Arkansas, 72202, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Bifidobacterium BB12 and Lactobacillus Rhamosus LGG (50%:50%) capsules.
Other names: live cultures
capsule manufactured to mimic probiotic capsules.
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.
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.
Arkansas Children's Hospital Research Institute
Other
Probiotic Supplementation in Obese Pregnant Women. A Feasibility Study.
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