Human Clinical Trial to Investigate the Effects of Resistant Starch Bagels on Risk Factors of Type 2 Diabetes and Colorectal Cancer in Adults at Risk for Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Fasting and postprandial blood glucose
研究概览
简要总结
The purpose of this study is to determine if consumption of bagels made with resistant starch for 8 weeks can improve markers of type 2 diabetes, colon cancer and satiety in adults.
详细描述
Using a randomized, double-blind crossover study design, we will determine the effect of consuming bagels made with resistant starch daily for 8-weeks can reduce the risk of type 2 diabetes and colon cancer in an adults who are at an increased risk for type 2 diabetes. Additionally, we will compare the satiating effect of these bagels to that of a standard bagel.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and postmenopausal females at least 40 year old
- •BMI ≥25 and <40 kg/m2
- •Waist circumference ≥ 102 cm for men, ≥88cm for women
- •CANRISK score ≥21 which indicates an elevated risk for type 2 diabetes
排除标准
- •Diabetes mellitus (fasting blood glucose ≥ 7.0 mmol/L)
- •Restrained eating habits
- •Gastrointestinal conditions (Celiac's disease, Crohn's disease, Ulcerative Colitis, Inflammatory Bowel Disease)
- •Renal Conditions
- •Hepatic Conditions
- •Surgery or major medical event within 3 months of study start date
- •Select medication use (Glycemia medications, cholesterol-lowering agents, antibiotics within 6 months of the study, other medications known to influence blood glucose insulin, cholesterol, triglycerides, incretin hormones of the digestive tract microbiome)
- •Select natural health product (NHP) use (Phytosterols or phytosterol functional foods, other NHPs intended for glycemic or cholesterol control)
- •Gluten allergy or intolerance
- •Alcohol consumption >15 drinks/week for men and >10 drinks/week for women
- •Significant international travel within 6 months of the starting the study, or plans to travel internationally during the study.
研究组 & 干预措施
Resistant Starch Bagels
Bagels made from high-resistant starch flour (provides 24g resistant starch per day)
干预措施: Resistant Starch (Other)
Control Bagels
Bagels made from wheat flour
干预措施: Resistant Starch (Other)
结局指标
主要结局
Fasting and postprandial blood glucose
时间窗: up to day 57 of both treatment periods
Blood glucose will be measured in the fasting state and postprandially (during a 3-hour oral glucose tolerance test) on the first and last study days of both treatment periods.
Fasting and postprandial insulin
时间窗: up to day 57 of both treatment periods
Circulating insulin will be measured in the fasting state and postprandially (during a 3-hour oral glucose tolerance test) on the first and last study days of both treatment periods.
次要结局
- HbA1c(Day 1 and 57 of both treatment periods)
- Calculated insulin sensitivity and beta-cell function(Days 1 and 57 of both treatment periods)
- Satiety-producing effect(Day 2,3 or 4 of both treatment periods)
研究者
Alison Duncan
Alison Duncan, Ph.D., R.D., Professor
University of Guelph