Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Anti-inflammatory Effects of the Fiber

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02868788
Recruitment Status : Recruiting
First Posted : August 16, 2016
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Paresh Dandona, University at Buffalo

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Dietary Supplement: dietary fiber Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Anti-inflammatory and ROS Suppressive Effects of the Fiber Supplementation to a High Fat High Calorie Meal in Patients With Type 2 Diabetes
Actual Study Start Date : June 14, 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Arm Intervention/treatment
high fat high calorie
Subjects in this arm will receive high fat high calorie meal
Dietary Supplement: dietary fiber
Other Name: 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 Name: Fiber One




Primary Outcome Measures :
  1. change in plasma reactive oxygen species generated by mononuclear cells from baseline [ Time Frame: 1 week ]
    mononuclear cells will be isolated by Ficoll-Hypaque method. reactive oxygen species will be measured by chemiluminescence as an index of NADPH oxidase activation

  2. change in plasma dipeptidyl peptidase IV enzyme level from baseline [ Time Frame: 1 week ]
    It will be measured by enzyme-linked immunosorbent assays


Secondary Outcome Measures :
  1. change in plasma Tumor Necrosis Factor level alpha from baseline [ Time Frame: 1 week ]
    RNA isolation and real time RT-PCR will be performed to measure expression of tumor necrosis factor alpha

  2. change in plasma Toll Like Receptor-4 level from baseline [ Time Frame: 1 week ]
    Toll Like Receptor-4 will be measured by Western Blots

  3. change in plasma Toll Like Receptor-2 level from baseline [ Time Frame: 1 week ]
    Toll Like Receptor-2 will be measured by Western Blots

  4. change in plasma level of Suppressor of Cytokine Signaling 3 from baseline [ Time Frame: 1 week ]
    Suppressor of Cytokine Signaling 3 will be measured by Western Blots

  5. change in plasma Protein Tyrosine Phosphatase-1B from baseline [ Time Frame: 1 week ]
    RNA isolation and real time RT-PCR will be performed to measure expression of Protein Tyrosine Phosphatase-1B

  6. change in plasma lipopolysaccharides level from baseline [ Time Frame: 1 week ]
    Lipopolysaccharide will be measured by commercially available kit (Cambrex Limulus Amebocyte Lysate kit, Lonza Inc. Walkersville, MD)

  7. change in plasma insulin level from baseline [ Time Frame: 1 week ]
    Insulin level will be measured by enzyme-linked immunosorbent assays

  8. change in plasma glucose level from baseline [ Time Frame: 1 week ]
    Glucose level will be measured by YSI 2300 STAT Plus glucose analyzer (Yellow Springs, Ohio)

  9. change in plasma incretin level from baseline [ Time Frame: 1 week ]
    Incretin level will be measured by enzyme-linked immunosorbent assays



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02868788


Contacts
Layout table for location contacts
Contact: Paresh Dandona, MD 716-898-1940 pdandona@kaleidahealth.org

Locations
Layout table for location information
United States, New York
ECMC Ambulatory Center, 3rd Floor Recruiting
Buffalo, New York, United States, 14215
Contact: Paresh Dandona, MD    716-898-1940    pdandona@kaleidahealth.org   
Contact: Jeanne Hejna, LPN    716-898-1944    jeannehe@buffalo.edu   
Sponsors and Collaborators
University at Buffalo

Layout table for additonal information
Responsible Party: Paresh Dandona, SUNY Distinguished Professor, University at Buffalo
ClinicalTrials.gov Identifier: NCT02868788     History of Changes
Other Study ID Numbers: 1977
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Paresh Dandona, University at Buffalo:
inflammation
insulin resistance
type 2 diabetes
obesity

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Anti-Inflammatory Agents