The Effect of Yogurt Enriched With Flaxseed on Cardiovascular Risk Factors in Type 2 Diabetic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 主要终点
- Change from baseline in values of FBS at 8 week
研究概览
简要总结
The investigators aimed to add flaxseed with high content of n-3 polyunsaturated fatty acids to low fat yogurt to obtain beneficial without adverse effects of it. In this parallel randomized controlled trial the investigators recruited 70 diabetic patients and randomly allocated to control and treatment groups. Participants in treatment group consumed 30 gr flaxseed in 200 gr low fat yogurt, while controls consumed 200 gr just low fat yogurt daily. Lipid profile, fasting blood sugar, glycosylated hemoglobin, systolic and diastolic blood pressure, weight, waist circumference and body mass index were measured at the first and end of the trial.
详细描述
Nutritionists have concern about consumption of full fat dairy in diabetic patients due to their content of saturated fatty acids. The investigators aimed to add flaxseed with high content of n-3 polyunsaturated fatty acids to low fat yogurt to obtain beneficial without adverse effects of it. In this parallel randomized controlled trial the investigators recruited 70 diabetic patients and randomly allocated to control and treatment groups. Participants in treatment group consumed 30 gr flaxseed in 200 gr low fat yogurt, while controls consumed 200 gr just low fat yogurt daily. Lipid profile, fasting blood sugar, glycosylated hemoglobin, systolic and diastolic blood pressure, weight, waist circumference and body mass index were measured at the first and end of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •BMI between 20 and 35 kg/m2 -
- •treated with oral hypoglycemic agents (Metformin or Glibenclamide)
- •no use of insulin
- •fasting blood glucose≥ 126 (but less than 400 mg/dl)or 2 hours blood sugar ≤ 200 mg/dl
- •no pregnancy and lactation
- •Blood lipids and blood pressure-lowering agents must remained unalteredwithin the last 3 months.
排除标准
- •Participants were excluded if they smoked, used alcohol, took dietary supplements containing Omega 3, phytoestrogens, antioxidants and fiber regularly, had been diagnosed with GI disease or renal, liver, cancer , inflammatory disease, had food allergies or intolerances
结局指标
主要结局
Change from baseline in values of FBS at 8 week
时间窗: 8 weeks
FBS: Fasting blood sugar
Change from baseline in values of HbA1c at 8 week
时间窗: 8 weeks
HbA1C: glycosylated hemoglobin
次要结局
- Change from baseline in values of body mass index at 8 week(8 weeks)
- Change from baseline in values of weight at 8 week(8 weeks)
- Change from baseline in values of blood pressure at 8 week(8 weeks)
- Change from baseline in values of waist circumference at 8 week(8 weeks)
- Change from baseline in values of Lipid profile (Total cholesterol, triglyceride, LDL-C, HDL-C) at 8 week(8 weeks)