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Carotenoid and Flavonoid Absorption From Red and Tangerine-Type Tomatoes

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01696773
First Posted: October 1, 2012
Last Update Posted: November 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jessica Cooperstone, Ohio State University
  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
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Enhancing Bioavailability and Nutritional Quality of Processed Tomato Products

Resource links provided by NLM:


Further study details as provided by Jessica Cooperstone, Ohio State University:

Primary Outcome Measures:
  • Pharmacokinetics of Carotenoid Absorption [ Time Frame: 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.


Enrollment: 12
Study Start Date: October 2012
Estimated Study Completion Date: June 2018
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jessica Cooperstone, Research Scientist, Ohio State University
ClinicalTrials.gov Identifier: NCT01696773     History of Changes
Other Study ID Numbers: 2012H0189
First Submitted: September 27, 2012
First Posted: October 1, 2012
Results First Submitted: October 14, 2014
Results First Posted: October 24, 2014
Last Update Posted: November 3, 2016
Last Verified: September 2016

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

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