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Assessment of Bioavailability of Phenolics From an Orange Peel Extract

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ClinicalTrials.gov Identifier: NCT02033330
Recruitment Status : Completed
First Posted : January 10, 2014
Last Update Posted : January 10, 2014
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:
In this study, the bioavailability of a specific orange peel extract is tested. The composition and morphology of the test product is altered compared to the generic product, which is used as a control. Due to intellectual property issues, more information cannot be given at this moment. Also the difference in bioavailability between a capsule and a lozenge is tested. The hypothesis is that the bioavailability of the altered extract will be improved compared to the control.

Condition or disease Intervention/treatment Phase
Improving Bioavailability Dietary Supplement: phenolics form orange peel Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Assessment of Bioavailability of Phenolics From an Orange Peel Extract
Study Start Date : July 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : January 2014

Arm Intervention/treatment
Active Comparator: phenolics form orange peel, type 1
1 dose of 500 mg of phenolics from orange peel, orally ingested
Dietary Supplement: phenolics form orange peel
Active Comparator: phenolics from orange peel, type 2
1 dose of 500 mg of phenolics from orange peel, orally ingested
Dietary Supplement: phenolics form orange peel
Experimental: phenolics from orange peel, type 3
1 dose of 500 mg of phenolics from orange peel, orally ingested
Dietary Supplement: phenolics form orange peel



Primary Outcome Measures :
  1. plasma concentrations of specific phenolics and their metabolites [ Time Frame: up to 24 hours ]

Secondary Outcome Measures :
  1. urine concentrations of specific phenolics and their metabolites [ Time Frame: 24 hours ]


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:

  • healthy adults
  • BMI 18.5 to 25

Exclusion Criteria:

  • pregnancy
  • smoking
  • alcohol or drug abuse
  • use of medication
  • use of nutritional supplements
  • abnormal liver or kidney function

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): NCT02033330


Locations
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Netherlands
Maastricht University Medical Centre
Maastricht, Netherlands, 6229ER
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Principal Investigator: Chris Van der Grinten, PhD Maastricht University Medical Center

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02033330     History of Changes
Other Study ID Numbers: Cordiart-PKA-1
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: January 2014
Keywords provided by Maastricht University Medical Center:
phenolics
orange peel
bioavailability