Artificial Sweeteners in Breast Milk: A Clinical Investigation With a Kinetic Perspective
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Breastmilk from mother
研究概览
简要总结
This study will investigate how some artificial sweeteners (AS) cross from blood to breastmilk in breastfeeding women after oral intake. Moreover, it will be investigated whether the kinetics of AS differ based on the women's body composition (BMI) and metabolic status (diabetes). This will be investigated through a clinical trial in which 60 women divided into three groups (normal weight, overweight and diabetic) will drink a beverage containing four AS. over a period of six hours the women will donate blood and breast milk samples in order to investigate the presence of AS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
All participants are given the same intervention and are aware of this
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Above 18 years old
- •Able to give consent
- •Able to produce enough amounts of breastmilk
- •Danish/English speakers
- •Pre-pregnancy BMI below 25 (20 subjects)
- •Pre-pregnancy BMI above 27 (20 subjects)
- •Diabetes type 1 or 2 (20 subjects)
排除标准
- •Under the age of 18 years old
- •Unable to give consent
- •Unable to produce enough amounts of breastmilk
- •Non-Danish/English speakers
- •If they have consumed artificial sweeteners 24 hours prior to trial
结局指标
主要结局
Breastmilk from mother
时间窗: Baseline, after 30 mins and afterwards once and hour for six hours
Concentration of artificial sweeteners in mother's breast milk
Blood from mother
时间窗: Baseline, after 30 mins and afterwards once and hour for six hours
Concentration of artificial sweeteners in mother's blood
次要结局
未报告次要终点