NCT02990637已完成不适用
The Effect of Olive Leaf Extract Administration on Cardiovascular Health
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Blood lipid profile
研究概览
简要总结
The purpose of this study is to investigate the effects of daily supplementation of OLECOL for a period of 8 weeks on cardiovascular risk markers.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- 是
入选标准
- •Healthy individuals
- •Age between 18 and 70 years
- •Total cholesterol levels ≥ 5.0 mmol/L
- •BMI 25-35 kg/m2
排除标准
- •History of severe cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat). Dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, allergy, major surgery and /or laboratory assessments that might limit participation in or completion of the study protocol.
- •Use of medication that might have influence on endpoints (e.g. cholesterol lowering medication, hypertension medication)
- •Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study in the 180 days prior to the study
- •Use of antibiotics in the 30 days prior to the start of the study
- •Use of antioxidants, minerals and vitamin supplements available in pharmacies, drugstores, food markets or in alternative medicine
- •Pregnancy, lactation
- •Abuse of products (> 20 alcoholic consumptions per week and drugs)
- •Weight gain or loss (> 3 kg in previous 3 months)
- •High physical activity (>4.5 hours of running/week)
- •History of any side effects towards intake of olives
结局指标
主要结局
Blood lipid profile
时间窗: 8 weeks
次要结局
- Glucose metabolism(8 weeks)
- Systolic and diastolic blood pressure(8 weeks)
- Lipid peroxidation(8 weeks)
研究者
Yala Stevens
MSc.
Maastricht University Medical Center
研究点 (1)
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