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Completed

NCT Number: NCT02348164

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USDA, ARS, Western Human Nutrition Research Center

Davis, California, 95616, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pink grapefruit first followed by tangerines two weeks later

Other

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 later

Other

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

USDA, Western Human Nutrition Research Center

Fed

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jan 28, 2015
Registry last updated
Jan 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.