Bioavailability of Pepper Carotenoids in Humans

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Tufts University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Tufts University
ClinicalTrials.gov Identifier:
NCT00636350
First received: March 7, 2008
Last updated: September 22, 2009
Last verified: September 2009
  Purpose

- list item one, Peppers

We propose to evaluate bio absorption of pepper carotenoids in a red bell-pepper or non-pungent green jalapeno pepper. The pepper will be provided in a cooked dish. The specific aims of this study are: 1) to determine blood response kinetics of lutein following multiple doses of non-pungent green jalapeno pepper with meals. 2) to determine blood response kinetics of zeaxanthin/capsanthin following multiple doses of red bell pepper with meals. We will feed 16 healthy man and women (50 - 65 y, females were at least one year post menopause), each cooked green jalapeno pepper or red pepper for 4 days and donate blood samples up to 21 days to determine blood response kinetics of xanthophylls following multiple doses of pepper dishes.


Condition Intervention Phase
Healthy
Dietary Supplement: Pepper
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Tufts University:

Primary Outcome Measures:
  • The enrichment of labeled pepper carotenoids in the serum samples after the meals. [ Time Frame: upto 21 days after the start of the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 5
Study Start Date: September 2007
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Pepper
    pepper carotenoids as meals
    Other Names:
    • pepper
    • lutein
    • xanthaphylls
Detailed Description:

- list item one, Peppers

Epidemiological data show that carotenoids and ß-C are health promoting when taken at physiologic levels in foods. However, human absorption and metabolism of carotenoids contained in various food matrices has not been studied well. It is important to investigate the characteristics of absorption and disposal kinetics after eating carotenoid rich foods in order to gain a basic understanding of the biological characteristics of lutein, zeaxanthin, and other carotenoids in food sources.

We propose to evaluate bio absorption of pepper carotenoids in a 2-phase research study: phase 1 will utilize red bell-pepper and phase 2 will utilize non-pungent green jalapeno pepper. The pepper will be provided as a dish in a meal. We will feed 16 healthy man and women (50 - 70 y, females were at least one year post menopause), each with red pepper (phase 1) and/or green jalapeno pepper (phase 2) for ~ 4 days and donate blood samples up to 21 days. Volunteers will be randomly assigned to one of the following two phases: phase 1 and phase 2.

The study will provide us the information on the bioavailability of pepper carotenoids.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteers

Exclusion Criteria:

  • GI track problems
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00636350

Locations
United States, Massachusetts
Tufts University
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
  More Information

No publications provided

Responsible Party: Guangwen Tang, Tufts University
ClinicalTrials.gov Identifier: NCT00636350     History of Changes
Other Study ID Numbers: 58-1950-7-707
Study First Received: March 7, 2008
Last Updated: September 22, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts University:
pepper carotenoids
xanthophylls
healthy volunteers

Additional relevant MeSH terms:
Carotenoids
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014