NCT01145066已完成2 期
Modulation of Biomarkers and Gene Expression by Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- hsCRP
研究概览
简要总结
This study will compare how well a combination of borage and echium oils will reduce inflammation compared to fish oils and placebo oil in subjects that are diabetic or have metabolic syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults, aged 21 years or more with either diabetes or metabolic syndrome. metabolic syndrome defined by NCEP/ATPIII criteria; must have 3 out of 5 of the following risk factors: 1.central obesity, men-greater than or equal to 40 inches, women-greater than or equal to 35 inches; 2.fasting blood TG greater than or equal to 150mg/dl or be taking TG lowering medications;
- •blood HDL cholesterol, men less than 40 mg/dl, women less than 50 mg/dl;
- •blood pressure greater than or equal to 130/85 or on HTN medication
- •fasting glucose greater than or equal to 100 mg/dl.
- •participants on statins or glucose lowering drugs if dosages are stable for 3 months
- •Exclusion criteria
- •children/young adults less than 21 years of age
- •currently using anti-inflammatory drugs including NSAIDS, oral/IV steroids or injection antiinflammatory drugs(for RA), aspirin greater than 100mg/day
- •taking leukotriene receptor antagonists ( montelukast), tylenol or nasal/inhaled steroids OK.
- •currently using niacin, fibrates or fish oil
- •blood pressure greater than 170/100
- •HB1Ac greater than 10%
- •TG greater than 500 mg/dl
- •myocardial infarction/vascular surgery/stroke within the past year
- •any stage II,III,IV heart failure
- •prior cholecystectomy
- •end stage renal disease
- •BMI less than 23 or greater than 45
- •pregnancy
- •alcohol use greater than 14 drinks per week
- •current self reported tobacco or illicit drug use
- •intolerance or allergy to fish oil
- •participants taking insulin on QD or BID doses, stable for 3 months
排除标准
- 未提供
研究组 & 干预措施
borage and echium oil combination
Experimental
borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA
干预措施: borage/echium oil combination (Drug)
fish oil
Active Comparator
Croda 18:12 fish oil
干预措施: fish oil (Dietary Supplement)
corn oil
Placebo Comparator
干预措施: corn oil (Dietary Supplement)
结局指标
主要结局
hsCRP
时间窗: 4 weeks and 8 weeks combined
Changes in high sensitive C-reactive protein (hsCRP) were assessed and data at 4 and 8 weeks was averaged..
Fasting Insulin
时间窗: 4 weeks and 8 weeks combined
Fasting insulin data at 4 and 8 weeks was averaged.
Leptin
时间窗: 4 weeks and 8 weeks combined
Data at 4 and 8 weeks was averaged.
次要结局
- Fasting Glucose(4 weeks and 8 weeks combined)
- SNPs in DNA of Selected Genes(4 weeks)
- Serum Fatty Acids(4 weeks and 8 weeks combined)
- Hemoglobin Levels(4 weeks and 8 weeks combined)
- Pro and Anti-inflammatory Cytokines(4 weeks and 8 weeks combined)
- Adipose Derived Cytokines(4 weeks)
- PBMC Gene Expression(4 weeks)
- PBMC Leukotriene Stimulation(4 weeks)
研究者
研究点 (1)
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