Anti-inflammatory and Reactive Oxygen Species (ROS) Suppressive Effects of the Fiber Supplementation to a High Fat High Carbohydrate Meal and Fiber Supplementation Alone in Obese Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Peak Change in From Baseline in Reactive Oxygen Species (ROS) Generation
研究概览
简要总结
This study will help elucidate the mechanism underlying the cardioprotective and anti-diabetes effect of dietary fiber by exploring a comprehensive set of inflammatory and oxidative stress markers, based on a contemporary understanding of this process. In addition, there have been very few studies that explored the immediate change in oxidative stress and incretin secretion after fiber intake. In this study, the investigators will be able assess the short term metabolic impact of dietary fiber at great details. The result will contribute to dietary recommendation or designing of fiber supplementation for prevention/treatment of diabetes, obesity and cardiovascular disease.
详细描述
Baseline labs include complete blood count (CBC), comprehensive metabolic panel (CMP), Hemoglobin A1C, and lipid profile. All labs will be drawn in the fasting state
Visit 1: Subjects will arrive after having fasted overnight (10 hours) at 7 to 7:30 am. An indwelling intravenous cannula will be placed in the anterior cubital vein for blood draws. A blood sample of the research labs and a urine sample will be collected. Blood pressure, heart rate and weight will be measured. Subjects will consume either a High Fat High Calorie (HFHC) meal or HFHC meal plus fiber (FiberOne Original cereal) according to randomization. Fiber will be consumed before and after the HFHC meal (28 grams in total, 14 grams before and after the meal). HFHC meal includes an egg muffin sandwich, a sausage muffin sandwich and two hash browns which contain 88g carbohydrate, 51 g fat (33% saturated) and 34 g protein. 35 ml of blood will be obtained at 1h , 2h, 3h and 5 h and 5 ml at 15 min,30 min,45 min,75 min and 90 min. A total of 165 ml (11 tablespoon) blood will be collected.
. Visit 2: Subjects will return 1 week later after overnight fasting (10 hours) at 7 to 7:30 am. Blood pressure, heart rate and weight will be measured. Baseline blood and urine samples will be collected again and subjects will be crossed over to receive the second meal (HFHC only or HFHC with fiber). Visit details are similar to visit 1. After this, the subject will be discharged from the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women 18 to 80 years of age
- •Non-smoker (last cigarette at least one month ago)
- •Type 2 diabetes for at least 1 year
- •Body mass index > 30 kg/m2
排除标准
- •Participation in any other concurrent clinical trials
- •Pregnancy or premenopausal women who are trying to be pregnant
- •Patients who are incompetent to give consent
- •Patients on non-steroidal anti-inflammatory drugs or steroids
- •Concurrent disease that could disrupt intestinal epithelium and increase permeability to endotoxin, ie Celiac and Crohns disease.
- •Hepatic disease (transaminase > 3 times normal)
- •Renal impairment (serum creatinine > 1.5 mg/dl)
- •History of drug or alcohol abuse
- •Use of over the counter or prescribed probiotic supplements.
- •Recent or current antibiotic use.
- •Coronary artery disease (CAD): documented by history of myocardial infarction, angioplasty/stent placement, angina, exercise EKG positive for ischemia or angiographic evidence of CAD
研究组 & 干预措施
high fat high calorie meal (HFHC)
Subjects in this arm will receive high fat high calorie (HFHC) meal only
干预措施: HFHC meal (Other)
HFHC plus fiber
Subjects in this arm will receive HFHC meal plus dietary fiber supplementation
干预措施: dietary fiber (Dietary Supplement)
HFHC plus fiber
Subjects in this arm will receive HFHC meal plus dietary fiber supplementation
干预措施: HFHC meal (Other)
结局指标
主要结局
Peak Change in From Baseline in Reactive Oxygen Species (ROS) Generation
时间窗: 5hr
mononuclear cells will be isolated by Ficoll-Hypaque method and ROS will be measured by chemiluminescence as an index of NADPH oxidase activation. Measurment will take place at baseline before the meal intervention and hourly for 5 hrs after the meal. The percent change from baseline at peak effect will be calculated.
次要结局
- Peak Change in From Baseline in Nuclear Factor-Kappa B (NFkB) Activation(5hr)
- Percent Change Toll Like Receptor-4 (TLR-4) Levels(5hr)
- Change in Plasma Lipopolysaccharides Level From Baseline.(5hr)
研究者
Paresh Dandona
SUNY Distinguished Professor
University at Buffalo