Clinical Study to Evaluate the Effect of a Food Supplement With Probiotics on the Metabolic Profile of Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Glucose homeostasis
研究概览
简要总结
The aim of this study is determine the effect of a food supplement with probiotics on metabolic profile and weight gain in pregnant women.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •> 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
结局指标
主要结局
Glucose homeostasis
时间窗: 30-32 weeks gestation
Glucose homeostasis status will be evaluated by measuring fasting glucose
次要结局
- Insulin levels(30-32 weeks gestation)
- Weight gain(30-32 weeks gestation)
- Insulin resistance(30-32 weeks gestation)
- Lipid concentration(30-32 weeks gestation)