This trial is active, not recruiting.

Condition carotenoid and flavonoid absorption
Treatments tangerine tomato juice, red tomato juice
Sponsor Ohio State University
Start date October 2012
End date September 2013
Trial size 12 participants
Trial identifier NCT01696773, 2012H0189


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics study
Intervention model crossover assignment
Masking open label
Primary purpose basic science
Tangerine tomato juice will be fed
tangerine tomato juice
Post-prandial feeding study
Red tomato juice will be fed
red tomato juice
Post-prandial feeding study

Primary Outcomes

Pharmacokinetics of carotenoid and flavonoid absorption
time frame: 11 post-prandial blood samples will be taken over 12 hours, as well as 24 hour urine collection

Secondary Outcomes

Effect of tomato supplementation on inflammation
time frame: One baseline sample and one post-prandial blood sample will be taken over 12 hours

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Enhancing Bioavailability and Nutritional Quality of Processed Tomato Products
Principal investigator Steven J Schwartz, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by Ohio State University.