NCT02662738已完成不适用
The Effect of a Natural Extract on Glucose Fluxes After Consumption of a Wheat Product
Unilever R&D2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2016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
- 12
- 试验地点
- 2
- 主要终点
- 13C (13 carbon) and D-[6,6-2H2] glucose
研究概览
简要总结
This study is to quantify the effect of a natural fruit extract added to a wheat product on the time needed to absorb 50% of the apparent total of available exogenous carbohydrate (RaE * Time). In addition the different glucose fluxes will be quantified (RaE, EGP and GCR)
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
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Caucasian male.
- •Body mass index (BMI) ≥ 18.0 and ≤ 25.0 kg/m
- •Apparently healthy: no medical conditions which might affect the study measurements including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery and inflammatory diseases.
- •Fasting blood glucose value of volunteer is ≥ 3.4 and ≤ 6.1 mmol/liter (i.e. 62- 110 mg/dl) at screening.
- •HbA1c ≤ 6.5 % (48 mmol/mol).
排除标准
- •Use of antibiotics within 3 months before Day 1; use of any other medication except paracetamol within 14 days before Day 1.
结局指标
主要结局
13C (13 carbon) and D-[6,6-2H2] glucose
时间窗: 0-6 hours
次要结局
- Total blood glucose (BG)(0-2 hours and 0-4 hours)
- Endogenous glucose production (EGP)(0-2 hours and 0-4 hours)
- Glucose clearance rate (GCR)(0-2 hours and 0-4 hours)
- Insulin(0-2 hours and 0-4 hours)
- 13C Metabolites of glucose (metabolomics)(0-2 hours and 0-4 hours)
- 12C Metabolites of glucose (metabolomics)(0-2 hours and 0-4 hours)
- Postprandial hormones (Gastric inhibitory polypeptide, glucagon-like peptide-1 and Glucagon)(0-2 hours and 0-4 hours)
- Selected anti-oxidants (vitamin E (alpha-tocopherol), lycopene, retinol, alpha-carotene and beta-carotene)(-5, 60, 120, 180, 240 and 300 minutes)
- Haematocrit(-5, 60, 120, 180, 240 and 300 minutes)
- Concentration of key active in extract(-5, 15, 30, 45, 60, 90, 120, 150, 180, 240, 300 and 360 minutes)
- 13CO2 in breath(30, 30, 60, 90,120, 150, 180 and every 30 minutes up to 6 hours)
研究者
研究点 (2)
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