Effects of GSH and N-Acetylcysteine on Inflammatory Markers Among Adults With CVD Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Inflammatory Markers
研究概览
简要总结
The rationale for the potential role of antioxidants in the prevention of cardiovascular diseases (CVD) remains strong despite the disappointing results of recent trials with a few select antioxidant vitamins. Glutathione (GSH) is one of the body's most powerful antioxidant agents but there is a surprising paucity of data on its use as an interventional therapy.
Glutathione, when taken orally, is immediately broken down into its constituent amino acids, of which cysteine is the only one to be essential. Available cysteine is the critical determinant of intracellular GSH concentrations. N-acetyl cysteine (NAC) is an antioxidant supplement that has been used to provide a source of cysteine to replete GSH levels. By replenishing endogenous glutathione, it is possible that NAC would exert the same effect(s) as exogenous GSH.
However, there is a new delivery system, liposomal GSH, which keeps glutathione intact. In this study, the investigators propose to match the cysteine content of NAC and GSH and compare the effects of these two supplements, at two different doses, on markers of inflammation and oxidative stress.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gender: Both women and men
- •Age: > or = 18 years
- •Ethnicity and race: All ethnic and racial backgrounds welcome
- •Presence of Metabolic Syndrome: As defined in ATP III of the National 5.Cholesterol Education program, the metabolic syndrome will be diagnosed as presence of at least three of the following, which will be measured at the screening clinic visit:
- •Central obesity as measured by waist circumference:
- •Men: Greater than 40 inches
- •Women: Greater than 35 inches
- •Fasting blood triglycerides greater than or equal to 150 mg/dL
- •Blood HDL cholesterol:
- •Men: Less than 40 mg/dL
- •Women: Less than 50 mg/dL
- •Blood pressure greater than or equal to 130/85 mmHg
- •Fasting glucose greater than or equal to 100 mg/dL
- •6.Planning to be available for clinic visits and bottle pick-ups for the 8 weeks of study participation 7.Ability and willingness to give written informed consent 8.No known active psychiatric illness.
排除标准
- •Daily intake of dietary supplements containing antioxidants or omega-3 FAs
- •Fasting blood glucose > 140 mg/dL
- •Significant liver enzyme abnormality
- •AST or ALT more than 2 times the upper limit of normal and/or
- •Bilirubin more than 50% the upper limit of normal
- •Renal disease as measured at baseline:
- •Serum creatinine > 1.30 mg/dL, or
- •Calculated creatinine clearance < 71 mL/min
- •Self reported personal history of:
- •Clotting disorders
- •Clinically significant atherosclerosis (e.g., CAD, PAD)
- •Malignant neoplasm
- •Ongoing infection
- •Inflammatory disease (e.g., rheumatoid arthritis)
- •Subjects currently receiving the following medications (self report):
- •Anti-Inflammatory drugs
- •Lipid lowering drugs including statins
- •Anti-hypertensive drugs
- •Anti-coagulant drugs
- •Body Mass Index (BMI) greater than or equal to
- •Pregnant or Lactating
- •Inability to communicate effectively with study personnel
研究组 & 干预措施
Placebo
Volume of liquid placebo product comparable to glutathione and 1 or 2 placebo pills/day.
干预措施: Placebo (Other)
Low-Dose N-Acetylcysteine
600 mg/day
干预措施: N-Acetylcysteine (Dietary Supplement)
High-Dose N-Acetylcysteine
1,200 mg/day
干预措施: N-Acetylcysteine (Dietary Supplement)
High-Dose Glutathione
2,260 mg/day
干预措施: Glutathione (Dietary Supplement)
Low-Dose Glutathione
1,130 mg/day
干预措施: Glutathione (Dietary Supplement)
结局指标
主要结局
Inflammatory Markers
时间窗: 8 weeks
次要结局
- Weight(8 weeks)
- Plasma Glutathione levels(8 weeks)
- Insulin Sensitivity(8 weeks)
- Blood pressure(8 weeks)
- Serum lipids(8 weeks)
- Insulin(8 weeks)
- Glucose(8 weeks)
- Oxidized LDL(8 weeks)
研究者
Christopher Gardner
Associate Professor of Medicine
Stanford University