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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.

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 groups in NCT02348164
Study groupRoleWhat they receive
Treatment 1ExperimentalVolunteers receive pink grapefruit first followed by tangerines two weeks later
Receives: Other: Pink grapefruit first followed by tangerines two weeks later
Treatment 2ExperimentalVolunteers 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.

  1. 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

  2. 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)
  1. 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

  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 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.

  1. First posted28 Jan 2015 (estimated)
  2. Study startDec 2007
  3. Primary completionFeb 2009
  4. Study completionFeb 2009

Resources

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)
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

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.

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