Anti-inflammatory Effects of the Fiber

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

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.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Dietary supplement: dietary fiber

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.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paresh Dandona, MD; Phone Number: 716-898-1940; Email: pdandona@kaleidahealth.org

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14215
      • Recruiting
      • ECMC Ambulatory Center, 3rd Floor
      • Contact: Paresh Dandona, MD; Phone Number: 716-898-1940; Email: pdandona@kaleidahealth.org
      • Contact: Jeanne Hejna, LPN; Phone Number: 716-898-1944; Email: jeannehe@buffalo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Men and women 18 to 80 years of age
2. Non-smoker (last cigarette at least one month ago)
3. Type 2 diabetes for at least 1 year
4. Body mass index > 30 kg/m2

Exclusion Criteria:

1. Participation in any other concurrent clinical trials
2. Pregnancy or premenopausal women who are trying to be pregnant
3. Patients who are incompetent to give consent
4. Patients on non-steroidal anti-inflammatory drugs or steroids
5. Concurrent disease that could disrupt intestinal epithelium and increase permeability to endotoxin, ie Celiac and Crohns disease.
6. Hepatic disease (transaminase > 3 times normal)
7. Renal impairment (serum creatinine > 1.5 mg/dl)
8. History of drug or alcohol abuse
9. Use of over the counter or prescribed probiotic supplements.
10. Recent or current antibiotic use.
11. Coronary artery disease (CAD): documented by history of myocardial infarction, angioplasty/stent placement, angina, exercise EKG positive for ischemia or angiographic evidence of CAD

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: high fat high calorie; Subjects in this arm will receive high fat high calorie meal	Dietary supplement: dietary fiber; Other Names: Fiber One
Experimental: high fat high calorie plus fiber; Subjects in this arm will receive high fat high calorie meal plus dietary fiber supplementation	Dietary supplement: dietary fiber; Other Names: Fiber One

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University at Buffalo

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2016
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: August 8, 2016
• First Submitted That Met QC Criteria: August 11, 2016
• First Posted (Estimate): August 16, 2016

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: November 2, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: obesity; type 2 diabetes; inflammation; insulin resistance
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 1977 (University of California, Irvine)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO