The Effect of 40gr Okara on Gastric Emptying
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To investigate the influence of 40 gram Okara on gastric emptying
研究概览
简要总结
The effect of 40gr Okara, on gastric emptying of standard meal (Muffin cake)
详细描述
This trail will be a single blinded, cross-over design. The study population will include 10 subjects. The patients will be randomly assigned to receive one of two Muffin cakes, with or without 40 grams Okara on three occasions (three visits). In two visits the subject will receive a Muffin cake with 40 grams Okara (but with similar caloric value), and in one visit a Muffin cake without Okara.
Postprandial gastric emptying time will be measured for each subject, by 13C Breath Test.
Okara is a natural water extracted food grade soy product, contains approximately 35% protein (mfb), and about 43% of dietary fibers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single
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
- •Healthy volunteers
- •Age 20-65 years old
- •Written Informed Consent
排除标准
- •History of gastro-intestinal surgery
- •On medication that may influence gastric emptying, or medication for weight loss
- •Patient on PPI treatment, H2 Blockers or medication for weight loss
- •Known allergies to soy
- •Pregnancy or breast-feeding
- •Metabolic syndrome or diabetes mellitus
- •Family history of metabolic syndrome or diabetes mellitus
- •Weight loss > 2 kg during two months before the study
结局指标
主要结局
To investigate the influence of 40 gram Okara on gastric emptying
次要结局
未报告次要终点