A Randomized, Controlled, Cross-over Study of the Effect of Oats on Post Prandial Glucose Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Blood Glucose
研究概览
简要总结
The objectives are to assess the effects of high viscosity vs. medium and low viscosity oat β-glucan on post-prandial glycemic response in healthy adult participants.
详细描述
The trial will be a 3 week double-blinded, randomized, cross-over design with 3 treatment intervention (oatmeal breakfasts costain low, medium and high viscosity of beta glucan) periods separated by about 5-7 days washout period. Normoglycemic (<5.6 mmol/L) males and females (12 of each) of age 18-45 y with a body mass index (BMI) of 18.5-29.9 kg/m2 will be recruited.
Each participant will receive each of the following breakfast foods in a random order: 1) oat meal containing low viscosity beta glucan; 2) oat meal containing medium viscosity beta glucan; 3) oat meal containing high viscosity beta glucan. The participants will be asked to consume one of the breakfast foods during each visit.
Following each blood sample, appetite, physical comfort, energy/fatigue, and palatability of treatments will be measured by visual analogue scales (VAS).
Glucose measurements: Capillary blood will be collected during each visit by finger prick. Blood will be collected at fasting and at 15, 30, 45, 60, 90 and 120 minutes after the first bite/sip of the test product according to the Clinical Laboratory Standard Institute (CLSI) guidelines. Blood glucose will be measured in finger prick blood samples by glucose meters .
Males will be scheduled for three sessions over 3 weeks. Women will be scheduled during the first two weeks of their menstrual cycle (follicular phase), once per week.
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
- Triple (Participant, 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
- •Normoglycemic (<5.6 mmol/L)
- •BMI= 18.5-29.9 kg/m²
排除标准
- •A change in medication (dose or type) or medical event requiring hospitalization within the past month.
- •Daily tobacco use.
- •Eat meals at irregular or unusual times.
- •Food allergy, aversion or unwillingness to eat study foods.
- •Use of any prescription or non-prescription drug, herbal or nutritional supplement known to affect blood sugar.
- •Presence of a gastrointestinal disorder.
- •Currently pregnant or lactating.
研究组 & 干预措施
Medium Viscous
Medium Viscous Beta Glucan Oatmeal
干预措施: Oatmeal (Other)
Low Viscous
Low Viscous Beta Glucan Oatmeal
干预措施: Oatmeal (Other)
High Viscous
High Viscous Beta Glucan Oatmeal
干预措施: Oatmeal (Other)
结局指标
主要结局
Blood Glucose
时间窗: 0-200 mins
Total area under the curve (iAUC, mmol\*min/L) for glucose
次要结局
- Appetite (visual analogue scales)(0-200 mins)
- Physical Comfort(0-200 mins)
- Energy/Fatigue(0-200mins)
- Palatability(at 5 mins)