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Completed

NCT Number: NCT02868788

Anti-inflammatory Effects of the Fiber

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.

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Key information

Conditions

Type 2 Diabetes Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Inflammation Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ECMC Ambulatory Center, 3rd Floor

Buffalo, New York, 14215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary fiber

Dietary Supplement

Fiber one supplement (32 grams of fiber) will be consumed with 910 Calorie HFHC meal

Other names: Fiber One

HFHC meal

Other

910 Calorie HFHC meal

Primary outcomes

  1. Peak Change in From Baseline in Reactive Oxygen Species (ROS) Generation

    Time frame: 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 outcomes

  1. Peak Change in From Baseline in Nuclear Factor-Kappa B (NFkB) Activation

    Time frame: 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

  2. Percent Change Toll Like Receptor-4 (TLR-4) Levels

    Time frame: 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.

  3. Change in Plasma Lipopolysaccharides Level From Baseline.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University at Buffalo

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 16, 2016
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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