Dose Ranging Study of the Effects of Alpha Lipoic Acid on Oxidative Stress
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 77
- 主要终点
- This study will provide information on the effect of a dose range of ALA on oxidative stress biomarkers.
研究概览
简要总结
Heart disease is the most common cause of death in the United States and it is commonly found in people with diabetes and high cholesterol. Inflammation is one mechanism by which diabetes and elevated cholesterol damage blood vessels. Inflammation can be increased by oxidative stress. This study will see if Alpha Lipoic acid, a potent antioxidant and over the counter product, reduces blood levels of markers of oxidative stress and inflammation when compared with placebo. Placebo is a substance that looks like the real product, but contains no active product.
详细描述
This is a randomized study. A randomized study means you will be assigned by chance (like the toss of a coin) to one of four groups and receive either alpha lipoic acid (ALA or placebo (an inactive substance that looks like the real drug). In this study, there is a 1 out of 4 chance you will receive placebo. Three of the groups will receive different doses of ALA and one group will receive placebo only. The groups are: placebo only, 600 mg ALA, 1200 mg ALA, and 1800 mg ALA a day. At some point all study participants will receive placebo; sometimes the pills will be ALA and sometimes they will be placebo. You will not know which you are taking on any given day.
This study is also double-blinded, which means that you, the study doctor, and the Sponsor will not know until the end of the study whether you are receiving ALA or placebo only. Your study doctor can find out if you are receiving ALA or placebo if needed in an emergency.
If you agree to be in this study, you will be asked to come in for up to 6 visits in 12 weeks. You should be fasting before some of these visits. Fasting means that you should have nothing to eat or drink, except water with your usual morning medications, for 10 hours before your scheduled study visit. The study staff will go over this with you each time.
Visit 1-Screening: (about 3 hours)
• Please fast before this visit
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 or more yrs,
- •Are able to give informed consent
- •Diabetic on stable doses of oral medications or diet or
- •Metabolic syndrome defined as having 3 or more of the following:
- •Impaired or fasting glucose > or = 100 mg/dL) or impaired glucose tolerance
- •Waist circumference > 40 inches in men and > 35 inches in women,
- •Hypertension (> or = 130/85 mmHg) or are on antihypertensive medication,
- •LDL < or = 50 mg/dL in females and < or = 40 mg/dL in men,
- •Triglyceride > or = 150 mg/dL
排除标准
- •Are on oral hypoglycemic drugs or insulin with HbA1c > 7.5,if diabetic,
- •On antioxidant supplementation and are unable or unwilling to stop,
- •A woman on hormone replacement therapy,
- •On medications that may have antioxidant or anti-inflammatory effects or effects on insulin sensitivity, e.g. HMGCo-A reductase inhibitor that cannot be discontinued for the duration of the study,
- •Current smoker (within 3 months prior to enrollment),
- •Have known coronary artery disease or stroke,
- •Have other diseases associated with active inflammation e.g. connective tissue disease, malignancy,
- •have a CRP > or = 10 mg/dl on screening blood with clinical evidence of inflammation
研究组 & 干预措施
placebo
Placebo 2 tabs three times daily
干预措施: Alpha lipoic acid at 3 doses compared to placebo (Dietary Supplement)
Alpha lipoic acid 1
Alpha lipoic acid 600 mg daily
干预措施: Alpha lipoic acid at 3 doses compared to placebo (Dietary Supplement)
Alpha lipoic acid 2
Alpha Lipoic acid 1200 mg daily
干预措施: Alpha lipoic acid at 3 doses compared to placebo (Dietary Supplement)
Alpha lipoic acid 3
Alpha lipoic acid 1800 mg daily
干预措施: Alpha lipoic acid at 3 doses compared to placebo (Dietary Supplement)
结局指标
主要结局
This study will provide information on the effect of a dose range of ALA on oxidative stress biomarkers.
时间窗: 3 months
次要结局
- To determine whether ALA improves vascular function through its effects on oxidative stress(3 months)
研究者
Pamela Ouyang
Professor of Medicine
Johns Hopkins University