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| Name | Class |
|---|---|
| Medical College of Wisconsin | OTHER |
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Pilot study to determine whether daily consumption of blackraspberry powder (high in polyphenols) can reduce markers of inflammation and to determine whether genetics influence baseline levels of inflammatory markers as well as individual's response to polyphenols. A total of 10 males participated in this cross-over study.
A high-fat, high-calorie challenge meal is administered to induce an inflammatory response in overweight and obese adult males. Serum levels of CRP, TNF-alpha, and IL-6 are measured prior to the challenge meal and at various times (1,2,4,8, and 12 hours) after the challenge meal. The challenge meal is given once without intervention and once after 5 daily doses of concentrated black-raspberry powder mixed in water.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blackraspberry slurry, washout, water | Experimental | Blackraspberry slurry daily x 5 days, 2 day washout, 8 oz. water daily x 5 days |
|
| Water, washout, Blackraspberry slurry | Experimental | 8 oz. water daily x 5 days, 2 day washout, Blackraspberry slurry daily x 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blackraspberry Slurry | Dietary Supplement | Blackraspberry slurry is 45 g blackraspberry powder mixed in 8oz. water. This is equivalent to 450 g fresh black raspberries. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum IL-6 | Area Under the time-concentration Curve (AUC) of IL-6 | acute (0-12 hours) after inflammation-causing challenge meal |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph P Kitzmiller, MD PhD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State Univesity | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23982695 | Result | Sardo CL, Kitzmiller JP, Apseloff G, Harris RB, Roe DJ, Stoner GD, Jacobs ET. An Open-Label Randomized Crossover Trial of Lyophilized Black Raspberries on Postprandial Inflammation in Older Overweight Males: A Pilot Study. Am J Ther. 2016 Jan-Feb;23(1):e86-91. doi: 10.1097/MJT.0b013e3182a40bf8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Water First, Then Washout, Then Blackraspberry Slurry | 8 oz. water daily x 5 days, 2 day washout, Blackraspberry slurry daily x 5 days |
| FG001 | Blackraspberry Slurry First, Then Washout, Then Water | Blackraspberry slurry daily x 5 days, 2 day washout, 8 oz. water daily x 5 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (6 Days) |
| |||||||||||||
| Washout (2 Days) |
| |||||||||||||
| Intervention 2 (5 Days) |
|
older obese and overweight males
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| ID | Title | Description |
|---|---|---|
| BG000 | Black-raspberry Powder | Black-raspberry powder: Black-raspberry powder (45g) equivalent to about 450 g fresh black raspberries |
| BG001 | No Intervention | Water without lypholized black raspberry powder |
| 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 | Serum IL-6 | Area Under the time-concentration Curve (AUC) of IL-6 | Posted | Mean | 95% Confidence Interval | (pg*hr)/mL | acute (0-12 hours) after inflammation-causing challenge meal |
|
|
1 month
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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 | Black-raspberry Slurry, Washout, Water | Black-raspberry Slurry: Black-raspberry powder (45g) equivalent to about 450 g fresh black raspberries. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joseph Kitzmiller | The Ohio State University | 6142928438 | joseph.kitzmiller@osumc.edu |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
|
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| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Water, Washout, Black-raspberry Slurry | Black-raspberry Slurry: Black-raspberry powder (45g) equivalent to about 450 g fresh black raspberries. | 0 | 5 | 0 | 5 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |