The Role of R-alpha Lipoic Acid in Prevention of Atherosclerotic Vascular Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Triglycerides
研究概览
简要总结
The purpose of this study is to see if a dietary supplement, R-alpha lipoic acid, is able to reduce risk factors such as body weight and high blood cholesterol levels in overweight or obese participants.
详细描述
The purpose of this study is to see if a dietary supplement, R-alpha lipoic acid, is able to reduce risk factors such as body weight and high blood cholesterol levels in overweight or obese participants.
Recruitment will be in the Portland, Oregon area.
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
- •Age 18-60
- •Overweight (BMI, 25.0-29.9 kg/m2) or obese (BMI, >30 kg/m2);
- •Elevated plasma triglycerides (100-400 mg/dl);
- •Weight stable for the last three months and at lifetime maximum;
- •Exercise limited to 30 minutes 3 times a week or less;
- •Hs-CRP level at baseline of ≤ 10 mg/L;
- •Consuming ≤ 2 alcoholic drinks per day;
排除标准
- •Pregnant, breastfeeding, or planning to become pregnant before the end of the study.
- •Having had acute medical conditions, such as hospitalizations or surgeries, at least three months prior to entry into the study
- •Diagnosed as having diabetes (fasting glucose <125 mg/dl for entry), cardiovascular disease, congestive heart failure, angina, thyroid disorders, cancer, inflammatory disorders or renal, hepatic, or hematological abnormalities;
- •Currently taking lipid-lowering drugs, anti-hypertensive drugs, insulin , or oral hypoglycemic agents, anti-inflammatory drugs, weight loss medications, or hormone replacement therapy;
- •On an extreme diet and not maintaining a prudent diet;
- •Currently taking vitamin or antioxidant supplements, including R-alpha lipoic acid, except standard multivitamin/mineral supplements containing not more than the Daily Value (DV) of the vitamins and minerals;
- •Smoking within the last three months;
研究组 & 干预措施
Placebo
Placebo two caps every morning on empty stomach
干预措施: Placebo (Dietary Supplement)
Lipoic Acid
600 mg R-alpha lipoic acid in morning on empty stomach (two 300 mg capsules)
干预措施: R-alpha lipoic acid (Dietary Supplement)
结局指标
主要结局
Triglycerides
时间窗: 12 weeks and 24 weeks
次要结局
- Body weight and composition(12 and 24 weeks)
- Markers of inflammation and oxidative stress(12 and 24 weeks)
研究者
Gerd Bobe
Principal Investigator, Linus Pauling Institute; Associate Professor, Department of Animal Sciences
Oregon State University