Effects of Non-nutritive Sweeteners on the Composition of the Gut Microbiome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 主要终点
- Taxa abundance before and after one-week of three times daily diet soda consumption
研究概览
简要总结
This pilot study is being conducted to evaluate whether consumption of diet soda sweetened with sucralose and acesulfame-potassium leads to changes in the gut microbiota. Following a one week run-in period, healthy, young adults are randomized to consume either diet soda or carbonated water (control) three times per day for one week. Stool and urine samples are collected at baseline, following the run-in, and after the one-week intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 18-35 years
- •Consume less than 1 food/beverage with non-nutritive sweeteners per month
- •Able and willing to consume diet soda three times daily for 1 week
排除标准
- •Recent diet or significant weight change
- •Antibiotic use in the past 3 months
- •Diarrhea in the past two weeks
- •Use of medications known to affect metabolism or weight
- •Weight < 50 kg (110 lbs.)
- •History of metabolic complications including high blood sugar, elevated cholesterol, or liver disease
结局指标
主要结局
Taxa abundance before and after one-week of three times daily diet soda consumption
时间窗: one week
16S rRNA and metagenomics sequencing will be used to determine microbial composition of stool samples before and after the one week intervention.
次要结局
未报告次要终点
研究者
Allison Sylvetsky (Meni)
Assistant Professor
George Washington University