Probiotic Supplementation in Obese Pregnant Women. A Feasibility Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in acceptance of probiotic supplementation throughout pregnancy in obese women.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •≥ 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
排除标准
- •• 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
结局指标
主要结局
Change in acceptance of probiotic supplementation throughout pregnancy in obese women.
时间窗: 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.
时间窗: 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.
次要结局
未报告次要终点