Effect of Dried Barberry Consumption on Cardiometabolic Risk Factors in Individuals With Mild to Moderate Hypertriglyceridemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Plasma concentration of high-density lipoprotein cholesterol (HDL-C)
研究概览
简要总结
Barberry is a well-documented medicinal plant that is utilized as a feed additive in a variety of food cultures. Barberry is a rich source of antioxidants, minerals, phenolic compounds, and flavonoids. Based on the results of animal and human studies, barberry may have therapeutic and medicinal properties, including the ability to improve blood lipid profile. The present study will investigate the effect of seedless barberry consumption on cardiometabolic factors in overweight or obese individuals with mild to moderate hypertriglyceridemia.
详细描述
This study is an open-label, randomized, controlled clinical trial and will recruit those who are willing to participate and meet the inclusion criteria. Inclusion criteria are fasting serum triglycerides 150-499 mg/dL, body mass index 25-40 kg/m2, age range 18-75 years. Exclusion criteria are regular use of drugs of the fibrate family, regular use of fish oil supplements or omega-3 supplements or flax seed or chia seed, treatment with glucocorticoids, end-stage renal disease. Subjects who agree to participate in the study will be randomly assigned to one of two study groups. All patients in both groups will be prescribed a low-calorie diet. In the first group, 10 grams of powdered seedless barberry will be consumed daily in addition to the low-calorie diet. The second group (control group) will continue with the low calorie diet. The study will last 8 weeks. Patients are asked to refrain from using over-the-counter herbal medicines and dietary supplements during the study. A baseline fasting blood sample, blood pressure measurements, and anthropometric indices will be obtained. Subsequent assessments will be made at four-week and eight-week intervals.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fasting serum triglycerides 150-499 mg/dL,
- •Body mass index 25-40 kg/m2
- •Age range 18-75 years
排除标准
- •Regular use of drugs of the fibrate family, fish oil supplements or omega-3 supplements
- •Regular consumption of flax seed or chia seed
- •Treatment with glucocorticoids
- •End-stage renal disease
结局指标
主要结局
Plasma concentration of high-density lipoprotein cholesterol (HDL-C)
时间窗: At baseline, the fourth week and the eighth week of study
The plasma HDL-C concentration 12 hours after the subjects had fasted
Plasma concentration of triglycerides
时间窗: At baseline, the fourth week and the eighth week of study
The plasma triglyceride concentration 12 hours after the subjects had fasted
次要结局
- Body weight(At baseline, the fourth week and the eighth week of study)
- Plasma Insulin(At baseline and the eighth week of study)
- Blood pressure(At baseline, the fourth week and the eighth week of study)
- Plasma Cholesterol(At baseline, the fourth week and the eighth week of study)
- Plasma C-reactive protein(At baseline and the eighth week of study)
- Urinary polyphenol(At baseline, the fourth week and the eighth week of study)
- Plasma proprotein convertase subtilisin/kexin type 9 (PCSK9)(At baseline and the eighth week of study)
研究者
Javad Nasrollahzadeh
Associate Professor
Shahid Beheshti University