NCT02497352已完成2 期
Effects of Flaxseed Supplementation in Metabolic Syndrome
National Nutrition and Food Technology Institute0 个研究点目标入组 44 人开始时间: 2014年2月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 主要终点
- Insulin resistance index (HOMA-IR)
研究概览
简要总结
To evaluate the effects of flaxseed supplementation on fasting blood sugar, lipid profile and anthropocentric measurements in subjects with metabolic syndrome, in a randomized, open-labeled, controlled pilot study, 44 subjects with metabolic syndrome will be received 30g/d flaxseed with lifestyle modification or lifestyle modification alone for 12 weeks. Both groups will be advised to follow an energy balanced diet and physical activity recommendations. Parameters related to metabolic syndrome will be measured at the baseline and at the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age and older
- •having three of the following five features: Increased waist circumference (≥102 cm in men and ≥88 cm in women), elevated TG (≥150 mg/dl), reduced HDL-C (≤40 mg/dl in men and ≤50 mg/dl in women), elevated blood pressure (≥130/85 mm Hg or on treatment for hypertension) and elevated glucose (≥100 mg/dl), according to the National Cholesterol Education Program Adult Treatment Panel III report
排除标准
- •history of allergy or high consumption of nuts, flaxseed, or sesame seeds
- •clinically diagnosed renal, liver, heart, pituitary, thyroid, or psychiatric disorders impairing the patient's ability to provide written informed consent
- •history of cardiovascular diseases, cancers, alimentary tract disorders affecting absorption
- •pregnancy, lactation, and lack of effective birth control in women of child-bearing potential
结局指标
主要结局
Insulin resistance index (HOMA-IR)
时间窗: 12 weeks
The homeostatic model assessment (HOMA)
次要结局
未报告次要终点
研究者
Dr Azita Hekmatdoost
Principal Investigator
National Nutrition and Food Technology Institute
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