NCT02853916已完成不适用
Efficacy of a Brown Seaweed Powder for Glycemic Control
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
- 22
- 试验地点
- 2
- 主要终点
- Incremental area under the curve (iAUC, mmol*min/L) of blood glucose
研究概览
简要总结
The objectives of this trial are to confirm efficacy in human of a brown seaweed powder and explore dose-response relationship by comparing two different doses.
The primary endpoint is incremental area under the curve (iAUC, mmol*min/L) for blood glucose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females aged between 18-45 y
- •Normoglycemic (fasting blood glucose <5.6 mmol/L)
- •Body mass index (BMI) 18.5-29.9 kg/m2
- •Able to consume bread products
- •Exclusion Criteria
- •Fasting blood glucose > 5.6 mmol/L
- •Systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg
- •Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorptive syndrome, pancreatitis, gallbladder or biliary disease
- •Presence of a gastrointestinal disorder within the past year
- •Presence of major gastrointestinal surgeries
- •Thyroid problems
- •Consuming prescription or non-prescription drug, herbal or nutritional supplements known to affect blood glucose or that could affect the outcome of the study as per investigator's judgement
- •Women that are currently pregnant or lactating, or not using an appropriate contraception method
- •Excessive alcohol intake (more than 2 drinks per day or more than 9 drinks per week)
- •Allergic to shellfish (crab) or molluscs
- •Weight gain or loss of at least 10lbs in previous three months
排除标准
- 未提供
研究组 & 干预措施
250 mg InSea2®
Active Comparator
干预措施: 250 mg InSea2® (Dietary Supplement)
Placebo
Placebo Comparator
干预措施: Placebo (Dietary Supplement)
500 mg InSea2®
Active Comparator
干预措施: 500 mg InSea2® (Dietary Supplement)
结局指标
主要结局
Incremental area under the curve (iAUC, mmol*min/L) of blood glucose
时间窗: 0, 15, 30, 45, 60, 75, 90, 120, 150, 180 and 210 min
Incremental area under the curve (iAUC, mmol\*min/L)
次要结局
未报告次要终点
研究者
研究点 (2)
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