Assessment of Bioavailability of Phenolics From an Orange Peel Extract

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Single (Participant)
  • Study Primary Completion Date: August 2013

Interventions

  • Dietary Supplement: phenolics form orange peel

Arms, Groups and Cohorts

  • Active Comparator: phenolics form orange peel, type 1
    • 1 dose of 500 mg of phenolics from orange peel, orally ingested
  • Active Comparator: phenolics from orange peel, type 2
    • 1 dose of 500 mg of phenolics from orange peel, orally ingested
  • Experimental: phenolics from orange peel, type 3
    • 1 dose of 500 mg of phenolics from orange peel, orally ingested

Clinical Trial Outcome Measures

Primary Measures

  • plasma concentrations of specific phenolics and their metabolites
    • Time Frame: up to 24 hours

Secondary Measures

  • urine concentrations of specific phenolics and their metabolites
    • Time Frame: 24 hours

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Maastricht University Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Chris Van der Grinten, PhD, Principal Investigator, Maastricht University Medical Center

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