Anti-inflammatory Effects of the Fiber
| Status: | Recruiting |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 11/8/2017 |
| Start Date: | June 14, 2016 |
| End Date: | July 2018 |
| Contact: | Paresh Dandona, MD |
| Email: | pdandona@kaleidahealth.org |
| Phone: | 716-898-1940 |
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.
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.
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.
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.
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
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