Study Results
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View full resultsBasic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2016-06-14
2018-07-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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high fat high calorie meal (HFHC)
Subjects in this arm will receive high fat high calorie (HFHC) meal only
HFHC meal
910 Calorie HFHC meal
HFHC plus fiber
Subjects in this arm will receive HFHC meal plus dietary fiber supplementation
dietary fiber
Fiber one supplement (32 grams of fiber) will be consumed with 910 Calorie HFHC meal
HFHC meal
910 Calorie HFHC meal
Interventions
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dietary fiber
Fiber one supplement (32 grams of fiber) will be consumed with 910 Calorie HFHC meal
HFHC meal
910 Calorie HFHC meal
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
80 Years
ALL
No
Sponsors
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University at Buffalo
OTHER
Responsible Party
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Paresh Dandona
SUNY Distinguished Professor
Locations
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ECMC Ambulatory Center, 3rd Floor
Buffalo, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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1977
Identifier Type: -
Identifier Source: org_study_id
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