Clinical trial NCT01696773: Carotenoid and Flavonoid Absorption From Red and Tangerine-Type Tomatoes
Official title: Enhancing Bioavailability and Nutritional Quality of Processed Tomato Products
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Carotenoid and Flavonoid Absorption
Keywords: tomato
tangerine tomato
carotenoids
lycopene
flavonoids
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2012-10-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetics of Carotenoid Absorption
timeFrame: 11 post-prandial blood samples will be taken over 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Clinical Research Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Steven J Schwartz, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.