Carotenoid and Flavonoid Absorption
Conditions
Keywords
tomato, tangerine tomato, carotenoids, lycopene, flavonoids
Brief summary
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).
Detailed description
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.
Interventions
OTHERTangerine tomato juice
Post-prandial feeding study
OTHERRed tomato juice
Post-prandial feeding study
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Total cholesterol ≤200 mg/dL * Triglycerides ≤ 200mg/dL * BMI 18.5 to 30.0kg/m2 * Not anemic (hemoglobin at or above 10g/dL and hematocrit at or above 30%) * Age 18-70 years
Exclusion criteria
* Lactating, pregnant, or plan to be pregnant during study * Tobacco (cigarettes and chewing tobacco) * Metabolic disease, such as diabetes mellitus or thyroid dysfunction * Malabsorption disorders (e.g. ileus, Crohn's, ulcerative colitis, pancreatic insufficiency) * History of cancer, esophageal, gastric, or intestinal ulcers * History of liver or kidney insufficiency or failure * Auto-immune disorders * Chronic inflammation (e.g. rheumatoid arthritis) * Allergies to tomatoes or tomato products * Obesity (BMI \> 30kg/m2) or underweight (BMI \<18.5kg/m2) * Hypercholesterolemia (Total cholesterol \> 200 mg/dL) * Triglycerides \> 200mg/dL * Subjects taking non-steroidal anti-inflammatory medications (e.g. Aspirin, Advil, Tylenol, Aleve) for 72 hours prior to each day-long visit. * Anemia (hemoglobin below 10g/dL or hematocrit below 30%) * Blood donation within the last 8 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of Carotenoid Absorption | 11 post-prandial blood samples will be taken over 12 hours | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tangerine Tomato Juice First, Then Red Tomato Juice Tangerine tomato juice is consumed on day 14 then red tomato juice on day 28 | 6 |
| Red Tomato Juice First, Then Tangerine Tomato Juice Red tomato juice is consumed on day 14, then tangerine tomato juice on day 28 | 6 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Days 15-27, Washout | Adverse Event | 1 | 0 |
Baseline characteristics
| Characteristic | Tangerine Tomato Juice First, Then Red Tomato Juice | Red Tomato Juice First, Then Tangerine Tomato Juice | Total |
|---|---|---|---|
| Age, Continuous | 22.8 years STANDARD_DEVIATION 2.8 | 29.0 years STANDARD_DEVIATION 13.4 | 25.9 years STANDARD_DEVIATION 9.8 |
| BMI | 23.1 kg/m^2 STANDARD_DEVIATION 1.4 | 25.5 kg/m^2 STANDARD_DEVIATION 1.6 | 23.3 kg/m^2 STANDARD_DEVIATION 1.4 |
| Hematocrit | 41.8 Volume % of red blood cells in blood STANDARD_DEVIATION 2.8 | 42.0 Volume % of red blood cells in blood STANDARD_DEVIATION 3.8 | 41.9 Volume % of red blood cells in blood STANDARD_DEVIATION 3.2 |
| Hemoglobin | 13.9 g/dL STANDARD_DEVIATION 0.8 | 14.1 g/dL STANDARD_DEVIATION 1.1 | 14.0 g/dL STANDARD_DEVIATION 1.1 |
| Plasma cholesterol (mg/dL) | 170.6 mg/dL STANDARD_DEVIATION 8.9 | 176.2 mg/dL STANDARD_DEVIATION 12.5 | 173.8 mg/dL STANDARD_DEVIATION 10.6 |
| Plasma triglycerides (mg/dL) | 65.8 mg/dL STANDARD_DEVIATION 49.3 | 85.8 mg/dL STANDARD_DEVIATION 42.3 | 75.8 mg/dL STANDARD_DEVIATION 45 |
| Region of Enrollment United States | 6 participants | 6 participants | 12 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 12 | 0 / 11 |
| serious Total, serious adverse events | 0 / 12 | 0 / 11 |
Outcome results
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.
Time frame: 11 post-prandial blood samples will be taken over 12 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tangerine Tomato Juice | Pharmacokinetics of Carotenoid Absorption | 690.9 nmol*h/L | Standard Error 117.8 |
| Red Tomato Juice | Pharmacokinetics of Carotenoid Absorption | 81.6 nmol*h/L | Standard Error 32.1 |