Carotenoid and Flavonoid AbsorptionNCT01696773
Carotenoid and Flavonoid Absorption From Red and Tangerine-Type Tomatoes
A study testing Tangerine tomato juice and Red tomato juice in people with Carotenoid and Flavonoid Absorption, run by Ohio State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Carotenoid and Flavonoid Absorption
- What is being tested?
- Tangerine tomato juice and Red tomato juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Dec 2027
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Clinical Research Center
Columbus, Ohio, 43210
About this study
Official title: 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).
Read the 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.
- Conditions
- Carotenoid and Flavonoid Absorption
- Being tested
- Tangerine tomato juice, Red tomato juice
- Keywords
- tomato, tangerine tomato, carotenoids, lycopene, flavonoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tangerine tomato juiceOther
Post-prandial feeding study
Red tomato juiceOther
Post-prandial feeding study
| Study group | Role | What they receive |
|---|---|---|
| Tangerine tomato juice | Experimental | Tangerine tomato juice will be fed Receives: Other: Tangerine tomato juice |
| Red tomato juice | Experimental | Red tomato juice will be fed Receives: Other: Red tomato juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of Carotenoid Absorption
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.
Measured: 11 post-prandial blood samples will be taken over 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionSep 2013
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carotenoid and Flavonoid AbsorptionStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Cooperstone, Ohio State University
- Investigators
- Steven J Schwartz, Ph.D., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696773
- Sponsor's protocol ID
- 2012H0189
- Status last verified
- Oct 2025
- First submitted
- 27 Sep 2012
- Last updated
- 20 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Do D, Sholola MJ, Cooperstone JL. Absorption and Metabolism of Steroidal Alkaloids from Tomato Juice in Healthy Adults: a Pharmacokinetic Study. Am J Clin Nutr. 2026 Oct 27:101597. doi: 10.1016/j.ajcnut.2026.101597. Online ahead of print.
PubMed 42946260Cooperstone 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.
PubMed 25620547
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Bioavailability and Nutritional Quality of Processed Tomato Products
- ClinicalTrials.gov ID
- NCT01696773
- Acronym / sponsor ID
- 2012H0189
- Conditions
- Carotenoid and Flavonoid Absorption
- Keywords
- tomato, tangerine tomato, carotenoids, lycopene, flavonoids
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 1 Oct 2012 (estimated)
- Results
- Posted 24 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tangerine tomato juice | Experimental | Other: Tangerine tomato juiceTangerine tomato juice will be fed |
| Red tomato juice | Experimental | Other: Red tomato juiceRed tomato juice will be fed |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tangerine tomato juicePost-prandial feeding study | Other | Tangerine tomato juice |
| Red tomato juicePost-prandial feeding study | Other | Red tomato juice |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42946260Do D, Sholola MJ, Cooperstone JL. Absorption and Metabolism of Steroidal Alkaloids from Tomato Juice in Healthy Adults: a Pharmacokinetic Study. Am J Clin Nutr. 2026 Oct 27:101597. doi: 10.1016/j.ajcnut.2026.101597. Online ahead of print.
- Derived from this study: PubMed 25620547Cooperstone 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven J Schwartz, Ph.D. principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tangerine tomato juice and Red tomato juice in people with Carotenoid and Flavonoid Absorption, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics of Carotenoid Absorption (time frame: 11 post-prandial blood samples will be taken over 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01696773, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.