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CompletedNCT02348164Updated Jan 28, 2015

Human Lycopene and Beta-cryptoxanthin Absorption From Citrus Fruit

An interventional study of Pink grapefruit first followed by tangerines two weeks later and Tangerines first followed by pink grapefruit two weeks later in Bioavailability of Carotenoids, sponsored by USDA, Western Human Nutrition Research Center. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-28.

Sponsored by USDA, Western Human Nutrition Research Center · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Bioavailability of Carotenoids

Keywords

  • Carotenoids
  • absorption
  • citrus
03

In context

Lead sponsor

USDA, Western Human Nutrition Research Center is the lead sponsor of 53 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Investigator)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    Treatment 1

    Volunteers receive pink grapefruit first followed by tangerines two weeks later

    Other: Pink grapefruit first followed by tangerines two weeks later

  • Experimental
    Treatment 2

    Volunteers receive tangerines first followed by pink grapefruit two weeks later

    Other: Tangerines first followed by pink grapefruit two weeks later

Interventions

  • OtherPink grapefruit first followed by tangerines two weeks later

    A 504 gram serving of pink grapefruit was fed as a single meal followed by 234 grams tangerines two weeks later

  • OtherTangerines first followed by pink grapefruit two weeks later

    A 234 gram serving of tangerines was fed as a single meal followed by 504 grams pink grapefruit two weeks later

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: Day 28 - 0, 3, 5, 7, 9, 21, and 24hr after meal

Secondary outcomes

  1. Change in blood lipids following meal ingestion

    Total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides will be measured with an automated Hitachi analyzer

    Time frame: 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

    Time frame: Day 28 - 0, 3, 5, 7, 9, 21, and 24hr after meal

07

Study locations

1 site
  • USDA, ARS, Western Human Nutrition Research Center
    Davis, California 95616, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02348164
Lead sponsor
USDA, Western Human Nutrition Research Center
Responsible party
Sponsor
First posted
Jan 28, 2015
Start date
Dec 2007
Primary completion
Feb 2009
Completion
Feb 2009
Last update
Jan 28, 2015

Study contacts

Betty J Burri, PhD
principal investigator · USDA, Western Human Nutrition Research Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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