NCT04697355已完成不适用
Case Study to Evaluate the Safety and Effect on Energy Expenditure of Naringenin and Beta Carotene
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Energy expenditure
研究概览
简要总结
This study is designed to test the effects of the combination of naringenin (from an extract of sweet oranges) and beta carotene on energy expenditure and glucose metabolism in a single human subject.
详细描述
The subject will be treated for 8 weeks with the combination of naringenin + beta carotene.
We will conduct the following assessments before the treatment and at the end of eight weeks.
- Resting metabolic rate
- Oral glucose tolerance test with glucose and insulin
- Ambulatory blood pressure
- Recording of adverse events
- Body weight
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fasting blood glucose < 200mg/dL
排除标准
- •Known allergy to citrus fruits
研究组 & 干预措施
Naringenin + Beta carotene
Experimental
Subject will ingest 300 mg naringenin three times/day and 6 mg beta carotene two times/day
干预措施: naringenin and beta carotene (Dietary Supplement)
结局指标
主要结局
Energy expenditure
时间窗: Five hours
Ventilated hood
Incidence of Treatment-Emergent Adverse Events
时间窗: Eight weeks
Adverse events
次要结局
- Glucose metabolism(Three hours)
- Blood pressure(24 hours)
- Body weight(16 weeks)
研究者
Frank Greenway
Chief Medical Officer
Pennington Biomedical Research Center
研究点 (1)
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