Assessment of Bioavailability of Phenolics From an Orange Peel Extract

January 9, 2014 updated by: Maastricht University Medical Center
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 6229ER
        • Maastricht University Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: Chris Van der Grinten, PhD, Maastricht University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

January 9, 2014

First Submitted That Met QC Criteria

January 9, 2014

First Posted (Estimate)

January 10, 2014

Study Record Updates

Last Update Posted (Estimate)

January 10, 2014

Last Update Submitted That Met QC Criteria

January 9, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Cordiart-PKA-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Improving Bioavailability

Clinical Trials on phenolics form orange peel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe