Assessment of Bioavailability of Phenolics From an Orange Peel Extract

NCT ID: NCT02033330

Last Updated: 2014-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Improving Bioavailability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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phenolics form orange peel, type 1

1 dose of 500 mg of phenolics from orange peel, orally ingested

Group Type ACTIVE_COMPARATOR

phenolics form orange peel

Intervention Type DIETARY_SUPPLEMENT

phenolics from orange peel, type 2

1 dose of 500 mg of phenolics from orange peel, orally ingested

Group Type ACTIVE_COMPARATOR

phenolics form orange peel

Intervention Type DIETARY_SUPPLEMENT

phenolics from orange peel, type 3

1 dose of 500 mg of phenolics from orange peel, orally ingested

Group Type EXPERIMENTAL

phenolics form orange peel

Intervention Type DIETARY_SUPPLEMENT

Interventions

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phenolics form orange peel

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chris Van der Grinten, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

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Maastricht University Medical Centre

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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Cordiart-PKA-1

Identifier Type: -

Identifier Source: org_study_id

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