Human Lycopene and Beta-cryptoxanthin Absorption From Citrus Fruit

NCT ID: NCT02348164

Last Updated: 2015-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Bioavailability of Carotenoids

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment 1

Volunteers receive pink grapefruit first followed by tangerines two weeks later

Group Type EXPERIMENTAL

Pink grapefruit first followed by tangerines two weeks later

Intervention Type OTHER

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

Treatment 2

Volunteers receive tangerines first followed by pink grapefruit two weeks later

Group Type EXPERIMENTAL

Tangerines first followed by pink grapefruit two weeks later

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

USDA, Western Human Nutrition Research Center

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Betty J Burri, PhD

Role: PRINCIPAL_INVESTIGATOR

USDA, Western Human Nutrition Research Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

USDA, ARS, Western Human Nutrition Research Center

Davis, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FL62 Citrus Study

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.