Post-prandial Glucose and Insulin Response to High-fiber Muffin Top Containing Resistant Starch in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- Blood glucose response
研究概览
简要总结
This randomized, double-blind, comparator controlled trial evaluated the blood glucose and insulin responses in healthy adults, after consuming a high fiber or low fiber muffin top.
详细描述
The fiber administered in this trial is a resistant starch type 4 derived from high-amylose maize starch. This product is high in dietary fiber (70% total dietary fiber (TDF), AOAC 2009.01 method) and can be used in a variety of bakery applications. The objective of this study was to evaluate the post-prandial blood glucose and insulin responses of healthy adults (n=28) after consuming a muffin top made with resistant starch or control muffin top, in a randomized, double-blind, crossover study. The muffin tops were matched for total weight, total carbohydrate, sugars, protein, and fat. During each 24-hour study period, subjects consumed a standard evening meal, fasted for 12 hours, and arrived at the study clinic the following morning. Serum glucose, serum insulin, and capillary glucose were measured after muffin top consumption. The subjects completed a seven day washout between treatments.
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
- Double (Participant, Investigator)
盲法说明
Study products were concealed in opaque foil envelopes. The treatments were identified by alphanumeric code. The subjects and investigators did not know the identity of the treatments.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older,
- •BMI 18.0-29.9 kg/m2,
- •fasting glucose ≤ 6.0 mmol/L;
- •if female, not of childbearing potential (e.g. taking oral contraceptives, past hysterectomy)
排除标准
- •diagnosed metabolic or chronic diseases (e.g. type-2 diabetes);
- •cancer diagnosis or treatment within 5 years;
- •gastrointestinal problems;
- •bowel cleansing during prior week;
- •current medications to control blood glucose;
- •current medications to control blood cholesterol ;
- •current medications to control blood pressure;
- •use of medical marijuana;
- •alcohol or drug abuse treatment in past 12 months;
- •allergy or sensitivity to study products;
- •blood donation in prior 2 months;
- •if female, currently pregnant, currently breastfeeding, or planning to become pregnant
结局指标
主要结局
Blood glucose response
时间窗: 0-4 hours after consumption
IV and capillary
次要结局
- Blood insulin response(0-4 hours after consumption)
- Breath hydrogen response(0-24 hours after consumption)