A Pilot Study to Test the Effect of Short Term Dietary Serine Supplementation on Circulating Serine Levels
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Circulating serine levels
研究概览
简要总结
This study will test the effect of short-term, high-dose dietary serine supplementation on circulating levels of serine. Individuals with risk factors for type 2 diabetes will be recruited into the 2 week study. Effects of dietary serine supplementation on glycemic measures will also be explored.
详细描述
This is a single-center, open-label, randomized, nutritional intervention study in adults. Subjects will have three visits to the Massachusetts General Hospital Clinical Research Center (CRC) during the 2 week study.
At the first study visit (Visit 1), the following will occur: informed consent; medical and nutritional history assessment; blood pressure, weight and height, fasting blood draw and blood work during a 2 hr oral glucose tolerance test; explanation and instructions for completion of a 4-day food log; randomized assignment to dose of dietary serine supplementation (6g, 12g, 24g, or 48g); provide 7 days of dietary serine supplements; take first dose of supplement with snack; schedule Visit 2 and Visit 3.
Between Visit 1 and Visit 2, participants will complete the Food Log and take the assigned dose of dietary serine supplementation 3 times daily.
Visit 2 will occur 7 days after Visit 1. Subjects will not take dietary serine supplementation prior to Visit 2 activities. At Visit 2, the following will occur: weight and blood pressure; fasting blood draw; administration of assigned dose of dietary serine supplementation with snack after blood work; review of the 4-day food log; provide 7 days of dietary serine supplements completion of anonymous survey to assess tolerability of supplement. Participants will continue to take the assigned dose of dietary serine supplementation 3 times daily between Visit 2 and Visit 3.
Visit 3 will occur 7 days after Visit 2. At Visit 3, the following will occur: weight and blood pressure; review of the 4-day food log; fasting blood draw and blood work during a 2 hr oral glucose tolerance test; completion of study survey to assess tolerability of the supplement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •risk factors for type 2 diabetes
排除标准
- •known type 2 diabetes
- •women who are pregnant, nursing, or not using contraception or abstinence
- •taking amino acid supplements during the study or at any time 1 month prior to enrollment in the study
- •conditions causing intestinal malabsorption, including celiac disease or a history of intestinal or gastric bypass surgery
- •known active liver disease
- •currently taking or intending to take during the study duration any medication known to affect glycemic parameters, such as glucocorticoids, growth hormone, or fluoroquinolones
- •participation in any other interventional study during the study duration
- •inability to adhere to study protocol.
结局指标
主要结局
Circulating serine levels
时间窗: 14 days
We will measure circulating serine levels after 14 days of intervention
次要结局
- Supplement tolerability(14 days)
- Fasting and post-prandial glucose(14 days)
研究者
Geoffrey Walford, MD
Physician
Massachusetts General Hospital