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Eating a diet rich in tomatoes has been associated with decreased risk for a variety of diseases. Tomatoes contain red-colored lycopene (one type of pigment in the class of pigments called carotenoids), which has been associated with the decreased risk of disease in those consuming tomato products; however, tomatoes also contain flavonoids, which may also have health promoting effects. The Tangerine tomato, a unique tomato variety, contains lycopene in a different form that in red tomatoes and this contributes to their characteristic orange color. This "orange lycopene" is more similar to the most common form of lycopene found in the blood and tissue of people who eat a tomato-rich diet, and may be more easily absorbed by the body.
The objectives of this study are to determine if carotenoids and flavonoids from Tangerine tomatoes are more easily absorbed by the body than red tomatoes, and to examine if eating Tangerine versus red tomatoes impacts markers of inflammation (response to harmful substances by the body).
The primary goal of this research is to determine if a processed Tangerine tomato product has enhanced bioavailability of carotenoids and flavonoids compared to a commercially available processed red tomato product in humans. This primary objective will be accomplished by quantifying carotenoids from post-prandial triglyceride-rich lipoprotein (TRL) fractions of plasma and flavonoids from whole plasma and urine, after subjects consume a meal containing Tangerine or red tomato juice. A secondary goal is to examine if short-term delivery of bioactives from Tangerine and red tomatoes impact markers of inflammation in humans. This secondary objective will be accomplished by analyzing plasma for both interleukin-6 (IL-6), a marker for inflammation, and RNA to assess alterations in transcription of genes that regulate inflammation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tangerine tomato juice | Experimental | Tangerine tomato juice will be fed |
|
| Red tomato juice | Experimental | Red tomato juice will be fed |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tangerine tomato juice | Other | Post-prandial feeding study |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of Carotenoid Absorption | The primary goal of this research is to determine if a processed tangerine tomato product has enhanced bioavailability of carotenoids and flavonoids compared to a commercially available processed red tomato product in humans. An area under the curve for concentration of carotenoids (from triglyceride rich lipoprotein (TRL) fraction of plasma) by using carotenoid concentrations from hours 0, 2, 3, 4, 5, 6, 8, 10 and 12 over time to quantify absorption, after subjects consume a meal containing tangerine or red tomato juice. | 11 post-prandial blood samples will be taken over 12 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven J Schwartz, Ph.D. | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Clinical Research Center | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25620547 | Derived | Cooperstone JL, Ralston RA, Riedl KM, Haufe TC, Schweiggert RM, King SA, Timmers CD, Francis DM, Lesinski GB, Clinton SK, Schwartz SJ. Enhanced bioavailability of lycopene when consumed as cis-isomers from tangerine compared to red tomato juice, a randomized, cross-over clinical trial. Mol Nutr Food Res. 2015 Apr;59(4):658-69. doi: 10.1002/mnfr.201400658. Epub 2015 Mar 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tangerine Tomato Juice First, Then Red Tomato Juice | Tangerine tomato juice will be fed, followed by a 14 day washout, and then red tomato juice will be fed |
| FG001 | Red Tomato Juice First, Then Tangerine Tomato Juice | Red tomato juice will be fed, followed by a 14 day washout, then tangerine tomato juice will be fed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Days 1-13, Washout |
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| Day 14, First Intervention |
| |||||||||||||
| Days 15-27, Washout |
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| Day 28, Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tangerine Tomato Juice First, Then Red Tomato Juice | Tangerine tomato juice is consumed on day 14 then red tomato juice on day 28 |
| BG001 | Red Tomato Juice First, Then Tangerine Tomato Juice |
| 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 | Pharmacokinetics of Carotenoid Absorption | The primary goal of this research is to determine if a processed tangerine tomato product has enhanced bioavailability of carotenoids and flavonoids compared to a commercially available processed red tomato product in humans. An area under the curve for concentration of carotenoids (from triglyceride rich lipoprotein (TRL) fraction of plasma) by using carotenoid concentrations from hours 0, 2, 3, 4, 5, 6, 8, 10 and 12 over time to quantify absorption, after subjects consume a meal containing tangerine or red tomato juice. | Posted | Mean | Standard Error | nmol*h/L | 11 post-prandial blood samples will be taken over 12 hours |
|
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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 | Tangerine Tomato Juice | Tangerine tomato juice will be fed Tangerine tomato juice: Post-prandial feeding study |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Menstrual distress | Reproductive system and breast disorders | 1 subject chose to dropout of the study 4 days after the first day long visit (at day 18). Adverse event categorized as sexual/reproductive function - other, menstrual distress - mild to moderate, not attributable or associated with the study agent. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven J. Schwartz | The Ohio State University | 614-292-2934 | schwartz.177@osu.edu |
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| Red tomato juice |
| Other |
Post-prandial feeding study |
|
| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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Red tomato juice is consumed on day 14, then tangerine tomato juice on day 28
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Plasma cholesterol (mg/dL) | Mean | Standard Deviation | mg/dL |
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| Plasma triglycerides (mg/dL) | Mean | Standard Deviation | mg/dL |
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| Hematocrit | Mean | Standard Deviation | Volume % of red blood cells in blood |
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| Hemoglobin | Mean | Standard Deviation | g/dL |
|
| Red Tomato Juice |
Red tomato juice will be fed Red tomato juice: Post-prandial feeding study |
|
|
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | Red Tomato Juice | Red tomato juice will be fed Red tomato juice: Post-prandial feeding study | 0 | 11 | 0 | 11 |
|
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