NCT02256332已完成不适用
Effect of Plant-based Ingredient on Post Prandial Glucose in Untreated Type II Diabetes Patients
Unilever R&D2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2015年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Post prandial blood glucose positive incremental area under the curve
研究概览
简要总结
Effects of a plant based ingredient on blood glucose in Type II diabetes patients.
详细描述
The study is designed to determine the extend to which a plant based ingredient in a food format affects blood glucose responses in untreated Type II diabetes patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female volunteers with confirmed Type II diabetes not treated with pharmaceutical-based glucose lowering treatment for past three months (controlled solely through diet and exercise);
- •Age ≥ 20 and ≤ 65 year at screening;
- •Body Mass Index (BMI) between ≥18 and ≤ 32 kg/m2;
- •HbA1c ≥48 mmol/mol and ≤53 mmol/mol (≥ 6.5% and ≤ 7.0%). At discretion of the study physician, subjects with HbA1c >53 mmol/mol and <58 mmol/mol (>7.0% and < 7.5%) controlled solely through diet and exercise are also allowed to participate.
排除标准
- •Being an employee of Unilever or research site;
- •Chronic smokers, tobacco chewers and drinkers;
- •No medication, including vitamins and tonics, except for cholesterol, as determined by the physician;
- •Reported weight loss/gain ≥ 10% of body weight in the 6 months preceding screening;
- •Allergy to any food or cosmetics;
- •If female, not being pregnant or planning pregnancy during the study period;
- •If female, lactating or has been lactating for 6 weeks before pre-study investigation and/or during the study period.
结局指标
主要结局
Post prandial blood glucose positive incremental area under the curve
时间窗: 120 minutes
次要结局
- Post prandial insulin area under the curve(120 minutes)
研究者
研究点 (2)
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