Anti-inflammatory Effects of the Fiber

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
high fat high calorie plus fiber	dietary fiber	Subjects in this arm will receive high fat high calorie meal plus dietary fiber supplementation
high fat high calorie	dietary fiber	Subjects in this arm will receive high fat high calorie meal

Primary Outcome Measures

Name	Time	Method
Peak Change in From Baseline in Reactive Oxygen Species (ROS) Generation	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.

Secondary Outcome Measures

Name	Time	Method
Peak Change in From Baseline in Nuclear Factor-Kappa B (NFkB) Activation	5hr	Nuclear factor-Kappa B (NFkB) activation will be measured at baseline before the meal and hourly up to 5 hrs and percent change from baseline at peak effect is calculated
Percent Change Toll Like Receptor-4 (TLR-4) Levels	5hr	Toll Like Receptor-4 will be measured by Western Blots at baseline before meal intake and hourly up to 5 hrs after meal. Percent change from baseline at peak effect is calculated.
Change in Plasma Lipopolysaccharides Level From Baseline.	5hr	Lipopolysaccharide will be measured by commercially available kit (Cambrex Limulus Amebocyte Lysate kit, Lonza Inc. Walkersville, MD). Measurements will take place at baseline before the meals and hourly for next 5 hrs. Percent change from baseline at peak effect is calculated.