NCT01384110已完成1 期
Efficacy of a Brown Seaweed Extract Rich in Polyphenols on Glycemic Response to Sucrose in Human
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Significant reduction in postprandial glycemia
研究概览
简要总结
The primary endpoint of this trial will be to evaluate if a single administration in human of a lemon ice tea containing 500 mg of a polyphenol-rich algal powder is able to reduce postprandial glycemia and insulinemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Healthy volunteer aged 18 to 60
- •BMI between 20 and 30
- •Non-smoking
- •Using valid contraceptive method (women of childbearing age)
排除标准
- •Iodine allergy, or allergy to components of the test product or placebo or standard meal
- •Use of dietary supplements for duration of study
- •History of gastro-intestinal affections, anemia, major surgeries or surgeries of the stomach or digestive tract
研究组 & 干预措施
Brown Seaweed Lemon Tea
Experimental
Single administration of lemon tea containing 500 mg of brown seaweed powder and 50 g of sucrose
干预措施: Reduction of glycemic index of ingested foods (Dietary Supplement)
Placebo lemon tea
Placebo Comparator
Single administration of placebo lemon tea containing 50 g of sucrose
干预措施: Reduction of glycemic index of ingested foods (Dietary Supplement)
结局指标
主要结局
Significant reduction in postprandial glycemia
时间窗: Immediately after product administration (single use)
Significant reduction in postprandial insulinemia
时间窗: Immediately after product administration (single use)
次要结局
- Frequency and severity of Adverse Events as a Measure of Safety and Tolerability(First administration up to 7 days after last administration)
研究者
研究点 (2)
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