Text Size

Carotenoid and Flavonoid Absorption From Red and Tangerine-Type Tomatoes

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Steven Schwartz, Ohio State University
ClinicalTrials.gov Identifier:
NCT01696773
First received: September 27, 2012
Last updated: November 27, 2012
Last verified: November 2012
History of Changes
  Purpose

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).


Condition Intervention
Carotenoid and Flavonoid Absorption
 Other: Tangerine tomato juice
Other: Red tomato juice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Enhancing Bioavailability and Nutritional Quality of Processed Tomato Products

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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) and flavonoids (from plasma) over time will be determined to quantify absorption, after subjects consume a meal containing Tangerine or red tomato juice. Urine will be used measure absorption/excreting of flavonoids over a 24 hour period.


Secondary Outcome Measures:
  • Effect of tomato supplementation on inflammation [ Time Frame: One baseline sample and one post-prandial blood sample will be taken over 12 hours ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 12
Study Start Date: October 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tangerine tomato juice
Tangerine tomato juice will be fed
 Other: Tangerine tomato juice
Post-prandial feeding study
Experimental: Red tomato juice
Red tomato juice will be fed
 Other: Red tomato juice
Post-prandial feeding study

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01696773

Locations
United States, Ohio
The Ohio State University Clinical Research Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Steven J Schwartz, Ph.D. Ohio State University
  More Information

No publications provided

Responsible Party: Steven Schwartz, Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT01696773     History of Changes
Other Study ID Numbers: 2012H0189
Study First Received: September 27, 2012
Last Updated: November 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
tomato
tangerine tomato
carotenoids
lycopene
flavonoids

Additional relevant MeSH terms:
Carotenoids
Antioxidants
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013