Nutrigenomics Approach to Investigate the Benefits of Dairy Product Consumption on Glucose Homeostasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Change from baseline to 6 weeks in insulin sensitivity between high dairy and dietary counselling phases
研究概览
简要总结
This study will investigate the in-depth the benefits of dairy consumption on glucose metabolism in patients at risk of type 2 diabetes using novel genomics methodology.To do so, 33 individuals at risk of type 2 diabetes will be randomly subjected to an intervention study including a 6-week intensive dairy product consumption period and a 6-week dietary counselling period.
详细描述
More than 9 million Canadians are living with diabetes or prediabetes. Type 2 diabetes is a disorder characterized by high blood glucose. Dietary modification is a key component in type 2 diabetes management. For example, dairy product consumption has beneficial effects on metabolic health. Yet, researchers have shown that mixed results exists for insulin sensitivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Caucasian men and postmenopausal women (absence of menstrual cycles for >12 months) aged >18 yrs;
- •BMI between 25-40 kg/m2;
- •Hyperinsulinemia (fasting plasma insulin >90 pmol/l);
- •Fasting plasma glucose (FPG) <7.0 mmol/l; HbA1c <6.5%);
- •If treated with lipid-lowering agents, the dose must have been stable over the last 3 months;
- •Stable body weight (±5%) for 3 months;
- •Willing to consume study foods and able to follow protocol and give informed consent.
排除标准
- •Failure to meet any one or more of the inclusion criteria;
- •Diagnosis of type 2 diabetes;
- •High dairy consumption ( 2 servings/day or more);
- •Major surgery in the 3 months prior to study onset;
- •Incompatibility with dairy consumption (allergy, intolerance or dislike);
- •Inflammatory bowel disease or other gastrointestinal disorder influencing gastrointestinal motility or nutrient absorption;
- •Medications known to affect lipid and glucose metabolism other than those used to treat hypertension or dyslipidemia;
- •Diseases known to affect glucose metabolism.
研究组 & 干预措施
Increased dairy product
Subjects will be asked to consume a total of 3 to 5 servings per day.They will be instructed on options and variations for incorporating the dairy foods into their routine dietary pattern.
干预措施: Increased dairy product (Behavioral)
Dietary counselling
Subjects will review the standard dietary recommendation(http://www.diabetes.ca/diabetes-and-you/nutrition/meal-planning-guide/) by a registered dietitian.
干预措施: Dietary counselling (Behavioral)
结局指标
主要结局
Change from baseline to 6 weeks in insulin sensitivity between high dairy and dietary counselling phases
时间窗: Change from 0 to 6 weeks
2h-oral glucose tolerance test (OGTT)
次要结局
- Change from baseline to 6 weeks in fasting glucose between high dairy and dietary counselling phases(Change from 0 to 6 weeks)
- Change from baseline to 6 weeks in fat mass between high dairy and dietary counselling phases(Change from 0 to 6 weeks)
- Change from baseline to 6 weeks in aortic stiffness (pulse wave velocity) between high dairy and dietary counselling phases(Change from 0 to 6 weeks)
- Change from baseline to 6 weeks in inflammatory profile (C-reactive protein, Tumor necrosis factor-alpha, Interleukin-6) between high dairy and dietary counselling phases(Change from 0 to 6 weeks)
- Change from baseline to 6 weeks in serum 25(OH) vitamin D between high dairy and dietary counselling phases(Change from 0 to 6 weeks)
- Change from baseline to 6 weeks in gene expression profiles between high dairy and dietary counselling phases(Change from 0 to 6 weeks)
- Change from baseline to 6 weeks in b-cell function (disposition index) between high dairy and dietary counselling phases(Change from 0 to 6 weeks)
- Change from baseline to 6 weeks in blood pressure between high dairy and dietary counselling phases(Change from 0 to 6 weeks)
- Change from baseline to 6 weeks in insulin secretion (Insulinogenic index ) between high dairy and dietary counselling phases(Change from 0 to 6 weeks)
- Change from baseline to 6 weeks in oxidative stress profile (F2-isoprostane profiles) between high dairy and dietary counselling phases(Change from 0 to 6 weeks)
- Change from baseline to 6 weeks in fatty acid profile between high dairy and dietary counselling phases(Change from 0 to 6 weeks)
- Change from baseline to 6 weeks in 2 h plasma glucose post OGTT between high dairy and dietary counselling phases(Change from 0 to 6 weeks)
- Change from baseline to 6 weeks in lipid profile (total-cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides) between high dairy and dietary counselling phases(Change from 0 to 6 weeks)
- Change from baseline to 6 weeks in metabolomics profiles between high dairy and dietary counselling phases(Change from 0 to 6 weeks)
- Change from baseline to 6 weeks in insulin secretion (area under the curve of C-peptide) between high dairy and dietary counselling phases(Change from 0 to 6 weeks)
- Change from baseline to 6 weeks in glucagon-like peptide-1 secretion between high dairy and dietary counselling phases(Change from 0 to 6 weeks)