Clinical trial NCT02868788: Anti-inflammatory Effects of the Fiber
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: inflammation
insulin resistance
type 2 diabetes
obesity
Lead sponsor: University at Buffalo
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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

Primary outcomes:
measure: Peak Change in From Baseline in Reactive Oxygen Species (ROS) Generation
timeFrame: 5hr
Secondary outcomes:
measure: Peak Change in From Baseline in Nuclear Factor-Kappa B (NFkB) Activation
timeFrame: 5hr
measure: Percent Change Toll Like Receptor-4 (TLR-4) Levels
timeFrame: 5hr
measure: Change in Plasma Lipopolysaccharides Level From Baseline.
timeFrame: 5hr
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: ECMC Ambulatory Center, 3rd Floor
state: New York
Study officials:
References: