Anti-inflammatory Effects of the Fiber

Study Overview
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Brief Summary
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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
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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.

Official Title
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Anti-inflammatory and ROS Suppressive Effects of the Fiber Supplementation to a High Fat High Calorie Meal in Patients With Type 2 Diabetes

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: dietary fiber


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: high fat high calorie<br>Subjects in this arm will receive high fat high calorie meal | Dietary Supplement: dietary fiber<br> <br> * Other names: Fiber One;|
| Experimental: high fat high calorie plus fiber<br>Subjects in this arm will receive high fat high calorie meal plus dietary fiber supplementation | Dietary Supplement: dietary fiber<br> <br> * Other names: Fiber One;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in plasma reactive oxygen species generated by mononuclear cells from baseline | mononuclear cells will be isolated by Ficoll-Hypaque method. reactive oxygen species will be measured by chemiluminescence as an index of NADPH oxidase activation | 1 week | 
| change in plasma dipeptidyl peptidase IV enzyme level from baseline | It will be measured by enzyme-linked immunosorbent assays | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in plasma Tumor Necrosis Factor level alpha from baseline | RNA isolation and real time RT-PCR will be performed to measure expression of tumor necrosis factor alpha | 1 week | 
| change in plasma Toll Like Receptor-4 level from baseline | Toll Like Receptor-4 will be measured by Western Blots | 1 week | 
| change in plasma Toll Like Receptor-2 level from baseline | Toll Like Receptor-2 will be measured by Western Blots | 1 week | 
| change in plasma level of Suppressor of Cytokine Signaling 3 from baseline | Suppressor of Cytokine Signaling 3 will be measured by Western Blots | 1 week | 
| change in plasma Protein Tyrosine Phosphatase-1B from baseline | RNA isolation and real time RT-PCR will be performed to measure expression of Protein Tyrosine Phosphatase-1B | 1 week | 
| change in plasma lipopolysaccharides level from baseline | Lipopolysaccharide will be measured by commercially available kit (Cambrex Limulus Amebocyte Lysate kit, Lonza Inc. Walkersville, MD) | 1 week | 
| change in plasma insulin level from baseline | Insulin level will be measured by enzyme-linked immunosorbent assays | 1 week | 
| change in plasma glucose level from baseline | Glucose level will be measured by YSI 2300 STAT Plus glucose analyzer (Yellow Springs, Ohio) | 1 week | 
| change in plasma incretin level from baseline | Incretin level will be measured by enzyme-linked immunosorbent assays | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inflammation, insulin resistance, type 2 diabetes, obesity