Human Lycopene and Beta-cryptoxanthin Absorption From Citrus Fruit

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

23

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

    • California
      • Davis, California, United States, 95616
        • USDA, ARS, Western Human Nutrition 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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment 1
Volunteers receive pink 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
Experimental: Treatment 2
Volunteers receive tangerines 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 14 - 0, 3, 5, 7, 9, 21, and 24hr after meal
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.
Day 28 - 0, 3, 5, 7, 9, 21, and 24hr after meal

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in blood lipids following meal ingestion
Time Frame: Day 14 - 0, 3, 5, 7, 9, 21, and 24hr after meal
Total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides will be measured with an automated Hitachi analyzer
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
Total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides will be measured with an automated Hitachi analyzer
Day 28 - 0, 3, 5, 7, 9, 21, and 24hr after meal

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Betty J Burri, PhD, USDA, Western Human Nutrition Research Center

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

December 1, 2007

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

January 21, 2015

First Submitted That Met QC Criteria

January 27, 2015

First Posted (Estimate)

January 28, 2015

Study Record Updates

Last Update Posted (Estimate)

January 28, 2015

Last Update Submitted That Met QC Criteria

January 27, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • FL62 Citrus Study

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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