Type 2 Diabetes Clinical Trial
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
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.
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.
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