The Effects of Consumption of Vitamin E or Lipoic Acid on Serum Oxyphytosterol Concentrations in Subjects With Impaired Glucose Tolerance or Type II Diabetes
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Plasma oxyphytosterol concentrations
研究概览
简要总结
Background of the study:
We now know that plant sterols can oxidize, which results in the formation of oxyphytosterols. Animal studies have suggested that oxyphytosterols are atherogenic components, however this relation has not yet been studied in humans. In our previous study (METC 09-3-088) we have shown in healthy volunteers that serum oxyphytosterol concentrations are linked to oxidative stress status (i.e. we were able to identify high and low sterol oxidizers). From the literature is known that especially type II diabetics and IGT subjects are characterized by increased oxidative stress markers and reduced antioxidant capacity. For this reason we also want to evaluate the oxyphytosterol concentrations in this population. Moreover, we know propose to evaluate the effect of antioxidant supplementation, i.e. vitamin E or lipoic acid, on serum oxyphytosterol concentrations in type II diabetic patients. If possible to lower oxyphytosterol concentrations in these populations this is obviously beneficial in case oxyphytosterols turn out to be atherogenic. The major objective of the present study is to examine the effect of consuming vitamin E (804 mg) or lipoic acid (600 mg) for 4 weeks on fasting oxyphytosterol concentrations in subjects with impaired glucose tolerance or type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 75 years
- •Body Mass Index (BMI) between 20-35 kg/m2
- •Mean serum total cholesterol <8.0 mmol/L
- •Mean serum triacylglycerol <3.0 mmol/L
- •Diagnosed with diabetes mellitus type 2 on a clinical basis or impaired glucose tolerance (defined as blood glucose >7.8 mmol/l and <11.0 mmol/L, two hours after ingesting 75 gram glucose in 150 ml water)
排除标准
- •Unstable body weight (weight gain or loss > 3 kg in the past two months)
- •Active cardiovascular diseases like congestive heart failure or recent (<6 months) event (acute myocardial infarction, cerebral vascular incident)
- •Severe medical conditions that might interfere with the study such as epilepsy, asthma, chronic obstructive pulmonary disease, inflammatory bowel disease and rheumatoid arthritis
- •Use of medication such as corticosteroids, diuretics or lipid lowering therapy
- •Use of insulin therapy
- •Abuse of drugs or alcohol (>21 units per week)
- •Not willing to stop the consumption of vitamin supplements, containing lipoic acid and/or vitamin E, 1 month before the start of the study (wash-in period)
- •Use of an investigational product within another biomedical study within the previous month
- •Pregnant or breast-feeding women
- •Current smoker
结局指标
主要结局
Plasma oxyphytosterol concentrations
时间窗: Measured after 4 weeks intervention
次要结局
- Markers reflecting oxidative stress(Measured after 4 weeks intervention)
- Markers reflecting antioxidant capacity(Measured after 4 weeks intervention)
- Serum lipoprotein concentrations(Measured after 4 weeks intervention)
研究者
Jogchem Plat
Professor
Maastricht University Medical Center