Bioavailability of CarotenoidsNCT02348164
Human Lycopene and Beta-cryptoxanthin Absorption From Citrus Fruit
A study testing Pink grapefruit first followed by tangerines two weeks later and Tangerines first followed by pink grapefruit two weeks later in people with Bioavailability of Carotenoids, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
Trial summary
The goal of the research study is to measure and compare the absorption of equivalent amounts of beta-cryptoxanthin and Iycopene provided in citrus fruit. The investigators want to determine whether adults absorb beta-cryptoxanthin to a greater extent than lycopene, when both are supplied in comparable citrus fruits. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability of Carotenoids
- What is being tested?
- Pink grapefruit first followed by tangerines two weeks later and Tangerines first followed by pink grapefruit two weeks later
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Feb 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-smoking
- Body mass indexes between 18 and 35
- Blood pressure under 150/90 mm Hg
- Not pregnant, lactating, or planning a pregnancy within 90 days.
Who cannot join
- Total cholesterol concentrations over 250 mg/dL
- Total fasting triacylglycerol concentrations over 175 mg/dL.
- Taking lipid-lowering medications (gemfibrozil, niacin, lovastatin, simvastatin)
- Taking fat blocking medications (such as orlistat)
- Taking medicines containing high dosages of retinoids such as Accutane
- Taking carotenoid dietary supplements
- Known allergy to tangerines or pink grapefruit
- Consuming more than 2 alcoholic drinks per day
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA, ARS, Western Human Nutrition Research Center
Davis, California, 95616
About this study
The goal of the research study is to measure and compare the absorption of equivalent amounts of beta-cryptoxanthin and Iycopene provided in citrus fruit. The investigators want to determine whether adults absorb beta-cryptoxanthin to a greater extent than lycopene, when both are supplied in comparable citrus fruits.
Read the detailed description
Lycopene and beta-cryptoxanthin are carotenoids found in a small number of foods. Unlike lycopene, beta-cryptoxanthin is among the 10% of carotenoids that can form vitamin A. Lycopene is primarily found in tomatoes and tomato-based products, but also in pink grapefruit and pink guava. Beta-cryptoxanthin is primarily found in tangerines, oranges, pumpkin, peaches, and papayas. Tomatoes and tomato products contain very high concentrations of lycopene, but beta-cryptoxanthin is present in modest amounts, of about 2 to 3 mg per serving, even in its primary food sources. Lycopene is typically the most abundant carotenoid in the diet and in the blood. Despite its scarcity in foods, beta-cryptoxanthin is the third or fourth most abundant carotenoid in blood.
This suggests that beta-cryptoxanthin absorption and metabolism may be quite different from the absorption and metabolism of lycopene and other carotenoids. Specifically, it suggests either that beta-cryptoxanthin itself is absorbed unusually well or that the citrus fruits that are the primary food sources of beta-cryptoxanthin in the diet are much more bioavailable than the tomato products that are the major source of lycopene. The investigators hypothesize that adults absorb a significantly greater amount of beta-cryptoxanthin than lycopene even when both carotenoids are supplied in comparable amounts in a similar matrix.
Subjects will be given a list of foods that are good sources of lycopene and beta-cryptoxanthin and asked to avoid them. Both carotenoids are found in limited numbers of foods, and can be avoided by limiting intakes of tomatoes, red and orange peppers, pumpkin, watermelon, pink guava, pink grapefruit, tangerines, oranges, papayas and mangos. The investigators will feed citrus fruit to volunteers in a randomized crossover design. On study days 14 and 28, subjects will receive either tangerines, or pink grapefruit in a randomized fashion so that each subject gets both treatments during the study. Each subject will serve as his/her own control, and will be fed both treatments at different times, separated by a two-week washout period.
On days 14 and 28, subjects will arrive at the Western Human Nutrition Research Center at approximately 10:30 AM. After a baseline blood draw, subjects will be fed their carotenoid-containing fruit with a controlled meal (low carotenoid, 30-35% fat). Subjects will be given a controlled, low carotenoid, 30-35% kcal from fat dinner at about 6:30 PM on treatment days (days 14 and 28) and a controlled low carotenoid, 30 - 35% kcals from fat breakfast at about 8 AM on study days 15 and 29. Investigators will collect 25 mL of blood per collection, by venipuncture of an arm vein at the following time points, 0, 3, 5, 7, 9, 21, and 24hr following the fruit containing meal. Blood will be collected into heparinized vacutainer tubes and placed on ice in a covered ice bucket.
- Conditions
- Bioavailability of Carotenoids
- Being tested
- Pink grapefruit first followed by tangerines two weeks later, Tangerines first followed by pink grapefruit two weeks later
- Keywords
- Carotenoids, absorption, citrus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pink grapefruit first followed by tangerines two weeks laterOther
A 504 gram serving of pink grapefruit was fed as a single meal followed by 234 grams tangerines two weeks later
Tangerines first followed by pink grapefruit two weeks laterOther
A 234 gram serving of tangerines was fed as a single meal followed by 504 grams pink grapefruit two weeks later
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 | Experimental | Volunteers receive pink grapefruit first followed by tangerines two weeks later Receives: Other: Pink grapefruit first followed by tangerines two weeks later |
| Treatment 2 | Experimental | Volunteers receive tangerines first followed by pink grapefruit two weeks later Receives: Other: Tangerines first followed by pink grapefruit two weeks later |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in carotenoid appearance in blood following fruit ingestion
Carotenoids (lycopene, lutein, beta-carotene and beta-cryptoxanthin), vitamin A and vitamin E will be measured with reverse-phase liquid chromatography diode array detection.
Measured: Day 14 - 0, 3, 5, 7, 9, 21, and 24hr after meal
Change in carotenoid appearance in blood following fruit ingestion
Carotenoids (lycopene, lutein, beta-carotene and beta-cryptoxanthin), vitamin A and vitamin E will be measured with reverse-phase liquid chromatography diode array detection.
Measured: Day 28 - 0, 3, 5, 7, 9, 21, and 24hr after meal
Secondary outcomes (2)
Change in blood lipids following meal ingestion
Total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides will be measured with an automated Hitachi analyzer
Measured: Day 14 - 0, 3, 5, 7, 9, 21, and 24hr after meal
Change in blood lipids following meal ingestion
Total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides will be measured with an automated Hitachi analyzer
Measured: Day 28 - 0, 3, 5, 7, 9, 21, and 24hr after meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startDec 2007
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioavailability of CarotenoidsStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA, Western Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Betty J Burri, PhD, Principal investigator, USDA, Western Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02348164
- Sponsor's protocol ID
- FL62 Citrus Study
- Status last verified
- Jan 2015
- First submitted
- 21 Jan 2015
- Last updated
- 28 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Lycopene and Beta-cryptoxanthin Absorption From Citrus Fruit
- ClinicalTrials.gov ID
- NCT02348164
- Acronym / sponsor ID
- FL62 Citrus Study
- Conditions
- Bioavailability of Carotenoids
- Keywords
- Carotenoids, absorption, citrus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- USDA, Western Human Nutrition Research CenterUS federal agency
- Study start
- Dec 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 28 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the research study is to measure and compare the absorption of equivalent amounts of beta-cryptoxanthin and Iycopene provided in citrus fruit. The investigators want to determine whether adults absorb beta-cryptoxanthin to a greater extent than lycopene, when both are supplied in comparable citrus fruits.
Detailed description
Lycopene and beta-cryptoxanthin are carotenoids found in a small number of foods. Unlike lycopene, beta-cryptoxanthin is among the 10% of carotenoids that can form vitamin A. Lycopene is primarily found in tomatoes and tomato-based products, but also in pink grapefruit and pink guava. Beta-cryptoxanthin is primarily found in tangerines, oranges, pumpkin, peaches, and papayas. Tomatoes and tomato products contain very high concentrations of lycopene, but beta-cryptoxanthin is present in modest amounts, of about 2 to 3 mg per serving, even in its primary food sources. Lycopene is typically the most abundant carotenoid in the diet and in the blood. Despite its scarcity in foods, beta-cryptoxanthin is the third or fourth most abundant carotenoid in blood.
This suggests that beta-cryptoxanthin absorption and metabolism may be quite different from the absorption and metabolism of lycopene and other carotenoids. Specifically, it suggests either that beta-cryptoxanthin itself is absorbed unusually well or that the citrus fruits that are the primary food sources of beta-cryptoxanthin in the diet are much more bioavailable than the tomato products that are the major source of lycopene. The investigators hypothesize that adults absorb a significantly greater amount of beta-cryptoxanthin than lycopene even when both carotenoids are supplied in comparable amounts in a similar matrix.
Subjects will be given a list of foods that are good sources of lycopene and beta-cryptoxanthin and asked to avoid them. Both carotenoids are found in limited numbers of foods, and can be avoided by limiting intakes of tomatoes, red and orange peppers, pumpkin, watermelon, pink guava, pink grapefruit, tangerines, oranges, papayas and mangos. The investigators will feed citrus fruit to volunteers in a randomized crossover design. On study days 14 and 28, subjects will receive either tangerines, or pink grapefruit in a randomized fashion so that each subject gets both treatments during the study. Each subject will serve as his/her own control, and will be fed both treatments at different times, separated by a two-week washout period.
On days 14 and 28, subjects will arrive at the Western Human Nutrition Research Center at approximately 10:30 AM. After a baseline blood draw, subjects will be fed their carotenoid-containing fruit with a controlled meal (low carotenoid, 30-35% fat). Subjects will be given a controlled, low carotenoid, 30-35% kcal from fat dinner at about 6:30 PM on treatment days (days 14 and 28) and a controlled low carotenoid, 30 - 35% kcals from fat breakfast at about 8 AM on study days 15 and 29. Investigators will collect 25 mL of blood per collection, by venipuncture of an arm vein at the following time points, 0, 3, 5, 7, 9, 21, and 24hr following the fruit containing meal. Blood will be collected into heparinized vacutainer tubes and placed on ice in a covered ice bucket.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 | Experimental | Other: Pink grapefruit first followed by tangerines two weeks laterVolunteers receive pink grapefruit first followed by tangerines two weeks later |
| Treatment 2 | Experimental | Other: Tangerines first followed by pink grapefruit two weeks laterVolunteers receive tangerines first followed by pink grapefruit two weeks later |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Non-smoking
- Body mass indexes between 18 and 35
- Blood pressure under 150/90 mm Hg
- Not pregnant, lactating, or planning a pregnancy within 90 days.
Key exclusion criteria (8 listed)
- Total cholesterol concentrations over 250 mg/dL
- Total fasting triacylglycerol concentrations over 175 mg/dL.
- Taking lipid-lowering medications (gemfibrozil, niacin, lovastatin, simvastatin)
- Taking fat blocking medications (such as orlistat)
- Taking medicines containing high dosages of retinoids such as Accutane
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 |
|---|---|---|
| Pink grapefruit first followed by tangerines two weeks laterA 504 gram serving of pink grapefruit was fed as a single meal followed by 234 grams tangerines two weeks later | Other | Treatment 1 |
| Tangerines first followed by pink grapefruit two weeks laterA 234 gram serving of tangerines was fed as a single meal followed by 504 grams pink grapefruit two weeks later | Other | Treatment 2 |
Primary outcome
Change in carotenoid appearance in blood following fruit ingestion
Time frame: Day 14 - 0, 3, 5, 7, 9, 21, and 24hr after meal
Carotenoids (lycopene, lutein, beta-carotene and beta-cryptoxanthin), vitamin A and vitamin E will be measured with reverse-phase liquid chromatography diode array detection.
Change in carotenoid appearance in blood following fruit ingestion
Time frame: Day 28 - 0, 3, 5, 7, 9, 21, and 24hr after meal
Carotenoids (lycopene, lutein, beta-carotene and beta-cryptoxanthin), vitamin A and vitamin E will be measured with reverse-phase liquid chromatography diode array detection.
2 secondary outcomes
Change in blood lipids following meal ingestion
Time frame: Day 14 - 0, 3, 5, 7, 9, 21, and 24hr after meal
Change in blood lipids following meal ingestion
Time frame: Day 28 - 0, 3, 5, 7, 9, 21, and 24hr after meal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2015.
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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.
Betty J Burri, PhD principal investigator
USDA, Western Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pink grapefruit first followed by tangerines two weeks later and Tangerines first followed by pink grapefruit two weeks later in people with Bioavailability of Carotenoids, run by USDA, Western Human Nutrition Research Center 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 28 Jan 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in carotenoid appearance in blood following fruit ingestion (time frame: Day 14 - 0, 3, 5, 7, 9, 21, and 24hr after meal). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2015.