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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high fat high calorie meal (HFHC) | Other | Subjects in this arm will receive high fat high calorie (HFHC) meal only |
|
| HFHC plus fiber | Experimental | Subjects in this arm will receive HFHC meal plus dietary fiber supplementation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dietary fiber | Dietary Supplement | Fiber one supplement (32 grams of fiber) will be consumed with 910 Calorie HFHC meal |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Change in From Baseline in Nuclear Factor-Kappa B (NFkB) Activation | Nuclear factor-Kappa B (NFkB) activation will be measured at baseline before the meal and hourly up to 5 hrs and percent change from baseline at peak effect is calculated | 5hr |
| Percent Change Toll Like Receptor-4 (TLR-4) Levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ECMC Ambulatory Center, 3rd Floor | Buffalo | New York | 14215 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | HFHC Meal Only First Then HFHC Meal Plus Fiber Second | Subjects in this arm will receive high fat high calorie (HFHC) meal first Then after 1 week will receive HFHC meal Plus Fiber |
| FG001 | HFHC Meal Plus Fiber First Then HFHC Meal Only Second | Subjects in this arm will receive high fat high calorie (HFHC) meal Plus Fiber first Then after 1 week will receive HFHC meal only |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Visit |
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| Second Visit (One Week Later) |
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CROSS-OVER STUDY. So, baseline information for both intervention groups is same
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Participants | All participants will randomly receive HFHC meal with or without dietary fiber supplementation in first visit and the other intervention in the second visit. Total 10 participants in cross-over design study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | percentage of change | 5hr |
|
5hr
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Fat High Calorie | Subjects in this arm will receive high fat high calorie meal dietary fiber |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paresh Dandona | State University of NY at Buffalo | 7165351852 | dandona@buffalo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 9, 2017 | Aug 27, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007249 | Inflammation |
| D007333 | Insulin Resistance |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| ID | Term |
|---|---|
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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| HFHC meal | Other | 910 Calorie HFHC meal |
|
Toll Like Receptor-4 will be measured by Western Blots at baseline before meal intake and hourly up to 5 hrs after meal. Percent change from baseline at peak effect is calculated. |
| 5hr |
| Change in Plasma Lipopolysaccharides Level From Baseline. | Lipopolysaccharide will be measured by commercially available kit (Cambrex Limulus Amebocyte Lysate kit, Lonza Inc. Walkersville, MD). Measurements will take place at baseline before the meals and hourly for next 5 hrs. Percent change from baseline at peak effect is calculated. | 5hr |
| NOT COMPLETED |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body mass index (BMI) | Mean | Standard Deviation | Kg/m^2 |
|
|
|
| Secondary | Peak Change in From Baseline in Nuclear Factor-Kappa B (NFkB) Activation | Nuclear factor-Kappa B (NFkB) activation will be measured at baseline before the meal and hourly up to 5 hrs and percent change from baseline at peak effect is calculated | Posted | Mean | Standard Error | percentage of change | 5hr |
|
|
|
| Secondary | Percent Change Toll Like Receptor-4 (TLR-4) Levels | Toll Like Receptor-4 will be measured by Western Blots at baseline before meal intake and hourly up to 5 hrs after meal. Percent change from baseline at peak effect is calculated. | Posted | Mean | Standard Error | percentage of change | 5hr |
|
|
|
| Secondary | Change in Plasma Lipopolysaccharides Level From Baseline. | Lipopolysaccharide will be measured by commercially available kit (Cambrex Limulus Amebocyte Lysate kit, Lonza Inc. Walkersville, MD). Measurements will take place at baseline before the meals and hourly for next 5 hrs. Percent change from baseline at peak effect is calculated. | Posted | Mean | Standard Error | percentage of change | 5hr |
|
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|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | High Fat High Calorie Plus Fiber | Subjects in this arm will receive high fat high calorie meal plus dietary fiber supplementation dietary fiber | 0 | 10 | 0 | 10 | 0 | 10 |
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| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D010829 |
| Physiological Phenomena |
| D019602 | Food and Beverages |