Clinical Safety and Pharmacokinetic Evaluation of Naringenin: Single Dose Escalation Randomized Double Blind Controlled Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Incidence of Treatment-emergent Adverse Events Following a Single Dose of a Citrus Extract of Naringenin
研究概览
简要总结
This study evaluates the safety of administering single ascending doses (150, 300, 600, and 900 mg) of a citrus extract of the flavonoid narigenin, and assesses the blood concentrations of naringenin following oral administration of the extract.
详细描述
Naringenin is a component of food with therapeutic potential to improve glucose metabolism. In order to explore the mechanisms by which naringenin may increase energy expenditure and improve glucose metabolism in humans, it is of vital importance that the safety, tolerability, and bioavailability of naringenin are evaluated, when administered to humans. This study tests the safety of four doses of a citrus extract of naringenin and measures serum concentrations of naringenin at the 150 mg and 600 mg doses over a period of 24 hours, and at the 300 and 900 mg doses at four hours after subjects have been given the respective doses of naringenin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Except for the pharmacist who will prepare and dispense the capsules, all study staff and the investigators will be blinded to the randomization.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult (≥18 years)
- •Body mass index between 20 and 35 kg/m2
- •Must have fasting blood sugar <126 mg/dL)
- •Must be willing to refrain from consuming citrus fruits and tomato in any form, for 36 hours prior to each test day.
排除标准
- •Report citrus allergies.
- •Report a history of cardiovascular disease, diabetes, or cancer
- •Have evidence of hepatic disease or dysfunction
- •Are currently pregnant or breastfeeding
- •Are women of childbearing potential who will not use an effective method of birth control
- •Chronically use of medications except over the counter medications that have been stopped 72 hours prior to the study visit
- •Report clinically significant GI malabsorption syndromes
- •Have clinically significant abnormal laboratory markers
- •Anticipate surgery during the study period.
- •Report history of substance abuse or alcoholism or significant psychiatric disorder that would interfere with the ability to complete the study.
- •Have donated blood during the month prior to study entry or plan to do so during the study.
- •Have participated in other studies using an investigational drug during the preceding three months.
- •Are current smokers or have smoked within the previous three months.
结局指标
主要结局
Incidence of Treatment-emergent Adverse Events Following a Single Dose of a Citrus Extract of Naringenin
时间窗: Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
All adverse events will be recorded following the first administration of the study product or placebo. The study physician in consultation with the coordinator will review and determine whether a subject can be administered the next ascending dose. The cohorts will be run in series. There will be an interval of up to four weeks between the two cohorts. During this time an interim analysis will be conducted and a safety summary of adverse events for Cohort 1 will be compiled and reviewed by the investigators. Dose safety will be investigated by compiling by treatment (e.g. 150 mg dose, 300 mg dose, placebo) a list of adverse events. The frequency of these events will be counted and compared with the placebo group.
次要结局
- Measurement of Area Under the Serum Naringenin Concentration Versus Time Curve at 150 and 600 mg Doses(0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours)
- Measurement of Time to Peak Concentration of Serum Naringenin at 150 and 600 mg Doses(24 hours)
- Measurement of Maximal Concentration of Serum Naringenin at 150 and 600 mg Doses(0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours)
- Measurement of Apparent Oral Clearance of Naringenin at 150 and 600 mg Doses(0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours)
- Measurement of Half Life of Naringenin at 150 and 600 mg Doses(0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours)
- Measurement of Four-hour Concentration of Serum Naringenin at 300 and 900 mg Doses(0 and 4 hours)
研究者
Candida Rebello
Postdoctoral Researcher
Pennington Biomedical Research Center