Anti-inflammatory Effects of the Fiber

NCT02868788 | Completed Results

• 1 other identifier: 1977
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

inflammation; insulin resistance; type 2 diabetes; obesity

Outcome Measures

Primary Outcomes (1)

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

  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.

  5hr

Secondary Outcomes (3)

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

  5hr

• Percent Change Toll Like Receptor-4 (TLR-4) Levels

  5hr

• Change in Plasma Lipopolysaccharides Level From Baseline.

  5hr

Study Arms (2)

high fat high calorie meal (HFHC)

OTHER

Subjects in this arm will receive high fat high calorie (HFHC) meal only

Other: HFHC meal

HFHC plus fiber

EXPERIMENTAL

Subjects in this arm will receive HFHC meal plus dietary fiber supplementation

Dietary Supplement: dietary fiber; Other: HFHC meal

Interventions

dietary fiber DIETARY_SUPPLEMENT

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

Also known as: Fiber One

HFHC plus fiber

HFHC meal OTHER

910 Calorie HFHC meal

HFHC plus fiber; high fat high calorie meal (HFHC)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University at Buffalo: lead

Study Sites (1)

ECMC Ambulatory Center, 3rd Floor

Buffalo, New York, 14215, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Inflammation; Insulin Resistance; Obesity

Interventions

Dietary Fiber

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Paresh Dandona
• Organization: State University of NY at Buffalo

dandona@buffalo.edu

7165351852

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: SUNY Distinguished Professor

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: August 16, 2016
• Study Start: June 14, 2016
• Primary Completion: January 1, 2018
• Study Completion: July 1, 2018
• Last Updated: October 17, 2024
• Results First Posted: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)