Assessment of Bioavailability of Phenolics From an Orange Peel Extract

Improving Bioavailability Clinical Trial

Official title:

Assessment of Bioavailability of Phenolics From an Orange Peel Extract

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02033330
• Other study ID #: Cordiart-PKA-1
• Status: Completed
• Phase: N/A
• First received: January 9, 2014
• Last updated: January 9, 2014
• Start date: July 2013
• Est. completion date: January 2014

Study information

• Verified date: January 2014
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: January 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Improving Bioavailability

Intervention

Dietary Supplement:
• phenolics form orange peel

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma concentrations of specific phenolics and their metabolites		up to 24 hours	No
Secondary	urine concentrations of specific phenolics and their metabolites		24 hours	No