Carotenoid and Flavonoid Absorption From Red and Tangerine-Type Tomatoes

January 22, 2024 updated by: Jessica Cooperstone, Ohio State University

Enhancing Bioavailability and Nutritional Quality of Processed Tomato Products

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
11 post-prandial blood samples will be taken over 12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Investigators

  • Principal Investigator: Steven J Schwartz, Ph.D., Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

September 27, 2012

First Submitted That Met QC Criteria

September 28, 2012

First Posted (Estimated)

October 1, 2012

Study Record Updates

Last Update Posted (Actual)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2012H0189

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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