NCT01570270已完成1 期
Cheese Intake and Hypercholesterolemia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 主要终点
- modification of LDL-cholesterol levels
研究概览
简要总结
In this study the investigators aimed at verifying whether consumption of a sheep cheese, naturally enriched in alpha-lipoic acid (ALA), conjugated linoleic acid (CLA) and vaccenic acid (VA), would modify the plasma lipid and endocannabinoid profiles in mild hypercholesterolemic subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •42 adult volunteers (19 male and 23 female) with diagnosed mild hypercholesterolemia (total cholesterol 220-290 mg/dL),
- •30-60 years of age
排除标准
- •Pregnant (or those planning to become pregnant during the study period) and lactating women were excluded;
- •also individuals with a self-reported history of diabetes, inflammatory bowel disease, pancreatitis, gallbladder or biliary disease in the past 12 months, and lactose intolerance before the screening visit.
- •In addition, those with a history of cancer (except non-melanoma skin cancer) in the 2 years before screening, or of any major trauma or surgical event within 3 months before screening, were not enrolled.
- •Volunteers with the following characteristics were also excluded:
- •total cholesterol ≥ 300 mg/dL,
- •serum triglycerides ≥ 250 mg/dL or ≤ 200 mg/dL,
- •HDL ≥ 70mg/dL,
- •BMI ≥ 30, or
- •uncontrolled hypertension (systolic blood pressure ≥ 160 mm Hg or
- •diastolic blood pressure ≥ 100 mm Hg) at screening.
结局指标
主要结局
modification of LDL-cholesterol levels
时间窗: baseline and 3 weeks
次要结局
未报告次要终点
研究者
Stefano Pintus
Principal Investigator
Azienda Ospedaliera Brotzu
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