Low-CArbohydrate Diet and SGLT2-INhibitOr to Achieve Moderate Ketosis in Healthy Volunteers (CASINO)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Fasting ketones
研究概览
简要总结
The purpose of this study is to help us better understand how plasma ketones respond to a low-carb diet when combined with an SGLT2 inhibitor.
详细描述
We will combine an SGLT2i with an adaptive study diet that gradually reduces dietary carbohydrates to safely achieve moderate ketosis in healthy adult volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Single, Experimental Group
SGLT2i + adaptive study diet of progressive dietary carbohydrate reduction
干预措施: SGLT2 inhibitor (Drug)
Single, Experimental Group
SGLT2i + adaptive study diet of progressive dietary carbohydrate reduction
干预措施: Controlled, Adaptive Study Diet (Other)
结局指标
主要结局
Fasting ketones
时间窗: 28 days
To determine if the primary study objective was achieved (e.g. SGLT2i combined with dietary carbohydrate restriction achieves moderate ketosis, safely and tolerably, in healthy, non-diabetic adults), we will use a binary decision (yes/no) for each participant, based on fasting capillary ketones.
次要结局
- 24h AUC plasma ketones(28 days)