Effects of Reduction in Saturated Fat on Cholesterol and Lipoproteins in Lean and Obese Persons
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Serum lipids in normal weight and obese subjects with elevated LDL cholesterol.
研究概览
简要总结
A randomized controlled clinical trial comparing the effect of substitution of unsaturated fat from nuts and oils for saturated fat from meat and dairy foods on serum lipids in normal weight and obese subjects with elevated LDL cholesterol.
详细描述
Background: Increased intake of saturated fat may influence LDL cholesterol and other cardiovascular risk factors different in normal weight and obese subjects. Methods: The study is a randomized controlled clinical trial in 84 men and women between 21 to 70 years with normal BMI (25 kg/m2) or obesity (BMI 30-45 kg/m2) and elevated LDL cholesterol (>3.0 mmol/l). Dietary intervention: Randomization will be to one of two balanced weight maintenance Mediterranean-type diets that differ in their fat sources: an intervention diet substituting unsaturated fats from oil and nuts for saturated fats from meat and dairy foods, and a control diet with whole fat dairy and meat with saturated fats that are not fat reduced.
Primary research question: Compare the effect of substitution of unsaturated fat from nuts and oils for saturated fat from meat and dairy foods on serum lipids in normal weight and obese subjects with elevated LDL cholesterol.
Secondary research questions: Compare the effect of substitution of unsaturated fat from nuts and oils for saturated fat on cardiometabolic risk factors including insulin resistance, inflammation and serum PCSK9 in normal weight and obese individuals.
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
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged 21 to 70 years with normal BMI (25 kg/m2) or obesity (BMI 30-45 kg/m2) and elevated LDL cholesterol (> 3.0 mmol/l).
排除标准
- •Diabetes types 1 and 2
- •History of CVD including myocardial infarction, percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), stroke, transient ischemic attack (TIA) or other atherosclerotic disease, eating disorder and other secondary causes of hyperlipidemia.
- •Use of statins or other cholesterol-modifying drugs.
- •Genetic lipid disorder.
- •Gastrointestinal disorders that limit food choices.
- •Psychiatric illness, drug or alcohol abuse.
研究组 & 干预措施
unsaturated fat
an intervention diet substituting unsaturated fats from oil and nuts for saturated fats from meat and dairy foods
干预措施: unsaturated fat for saturated fat (Other)
saturated fat
a control diet with whole fat dairy and meat with saturated fats that are not fat reduced.
干预措施: saturated fat (Other)
结局指标
主要结局
Serum lipids in normal weight and obese subjects with elevated LDL cholesterol.
时间窗: 10 weeks
Compare the effect of substitution of unsaturated fat from nuts and oils for saturated fat from meat and dairy foods on serum lipids in normal weight and obese subjects with elevated LDL cholesterol.
次要结局
- Serum PCSK9 in normal weight and obese individuals(10 weeks)
- C-reactive protein in normal weight and obese individuals(10 weeks)
- Fasting glucose and HbA1C(10 weeks)
研究者
Tine Mejlbo Sundfør
M.Sc in Nutrition
Oslo University Hospital