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Trial record 2 of 2 for:    absorption | Citrus reticulata

Human Lycopene and Beta-cryptoxanthin Absorption From Citrus Fruit

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ClinicalTrials.gov Identifier: NCT02348164
Recruitment Status : Completed
First Posted : January 28, 2015
Last Update Posted : January 28, 2015
Sponsor:
Information provided by (Responsible Party):
USDA, Western Human Nutrition Research Center

Brief 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.

Condition or disease Intervention/treatment Phase
Bioavailability of Carotenoids Other: Pink grapefruit first followed by tangerines two weeks later Other: Tangerines first followed by pink grapefruit two weeks later Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: Human Lycopene and Beta-cryptoxanthin Absorption From Citrus Fruit
Study Start Date : December 2007
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Lycopene

Arm Intervention/treatment
Experimental: Treatment 1
Volunteers receive pink grapefruit first followed by tangerines two weeks later
Other: 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
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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02348164


Locations
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United States, California
USDA, ARS, Western Human Nutrition Research Center
Davis, California, United States, 95616
Sponsors and Collaborators
USDA, Western Human Nutrition Research Center
Investigators
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Principal Investigator: Betty J Burri, PhD USDA, Western Human Nutrition Research Center

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Responsible Party: USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT02348164     History of Changes
Other Study ID Numbers: FL62 Citrus Study
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: January 28, 2015
Last Verified: January 2015
Keywords provided by USDA, Western Human Nutrition Research Center:
Carotenoids
absorption
citrus
Additional relevant MeSH terms:
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Beta-Cryptoxanthin
Lycopene
Anti-Inflammatory Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Provitamins
Vitamins
Micronutrients
Nutrients
Growth Substances