Risk and Prevention Study: Optimisation of the Preventive Strategies and Evaluation of the Efficacy of n-3 Fatty Acids in Subjects at High Cardiovascular Risk and Suboptimal Health Status
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 422
- 试验地点
- 3
- 主要终点
- the improvement of suboptimal health status
研究概览
简要总结
The purpose of this study is to determine whether omega-3 fatty acids supplementation are effective in the improvement of suboptimal health status and cardiovascular risk.
详细描述
The Suboptimal health status questionnaire (SHSQ-25) is used to evaluate the suboptimal health status. The SHSQ-25 includes 25 questions. The score of the SHSQ-25 is from 0 to 100. Suboptimal health status is defined as the SHSQ-25 score above than 35. The higher scores of the SHSQ-25 one gets, the more severity of suboptimal health status he/she has. All participants are asked to fill in the SHSQ-25 before and after the intervention. If the score decreases after the intervention, it means that the suboptimal health status has been improved.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •suboptimal health status, defined as the score of suboptimal health questionnaire ≥
- •at least one of cardiovascular risk factors:
- •overweight or obesity, defined as body mass index (BMI) ≥25 kg/m
- •systolic blood pressure ≥130 and <140 mmHg and diastolic blood pressure <90 mmHg, or diastolic blood pressure ≥85 and <90 mmHg and systolic blood pressure <140 mmHg
- •fasting plasma glucose ≥100 and <126 mg/dL
- •total cholesterol ≥200 and <240 mg/dL, triglyceride ≥150 and <200 mg/dL, low density lipoprotein-cholesterol ≥130 and <160 mg/dL,and/or high density lipoprotein-cholesterol <40 mg/dL
- •written informed consent
排除标准
- •history of system diseases, such as cardiovascular diseases, digestive system diseases, diseases of respiratory system, blood and immune system diseases, nervous system diseases, endocrine system diseases, and diseases of the genitourinary system.
- •history of mental illness.
- •pregnant or breastfeeding.
- •use of antihypertensive, antidiabetic, or lipid-lowering drugs within the past two weeks.
- •use of fish oil capsules or other supplements containing omega-3 fatty acids within the past two weeks.
- •allergy or intolerance to fish oil, corn oil, omega-3 fatty acids, or vitamin E.
- •participation in another trial.
- •unable to promise to not use drugs and other fish oils during the study.
- •unable to provide informed written consent.
研究组 & 干预措施
Omega-3 fatty acid capsules
Omega-3 fatty acid capsules, 4 g/day, requiring intake 2 capsules (1g each one) in the morning and two at night for 3 months.
干预措施: Omega -3 fatty acids (Dietary Supplement)
corn oil
Corn oil in similar presentation as omega-3 fatty acid capsules, requiring intake 2 capsules in the morning and two at night for 3 months.
干预措施: Placebo: Corn oil (Dietary Supplement)
结局指标
主要结局
the improvement of suboptimal health status
时间窗: three months
The improvement of suboptimal health status is evaluated by the change of the SHSQ-25 scores after intervention.
the improvement of traditional cardiovascular risk factors
时间窗: three months
To investigate the changes of traditional cardiovascular risk factors such as blood pressure, lipids, fasting plasma glucose, and body mass index with three months supplementation of omega-3 fatty acids. Abnormal cardiovascular risk factors are defined according to the Adult Treatment Panel III criteria for metabolic syndromes and the recommendation by the Working Group on Obesity in China. The number of abnormal cardiovascular risk factors for each participant is recorded before and after intervention. If the number decreases after intervention, it means that the traditional cardiovascular risk factors have been improved.
次要结局
未报告次要终点
研究者
Qiang Zeng, MD
Professor
Chinese PLA General Hospital