Improving BioavailabilityNCT02033330
Assessment of Bioavailability of Phenolics From an Orange Peel Extract
A study testing phenolics form orange peel in people with Improving Bioavailability, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Improving Bioavailability
- What is being tested?
- phenolics form orange peel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy adults
- BMI 18.5 to 25
Who cannot join
- pregnancy
- smoking
- alcohol or drug abuse
- use of medication
- use of nutritional supplements
- abnormal liver or kidney function
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Improving Bioavailability
- Being tested
- phenolics form orange peel
- Keywords
- phenolics, orange peel, bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phenolics form orange peelDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| phenolics form orange peel, type 1 | Active comparator | 1 dose of 500 mg of phenolics from orange peel, orally ingested Receives: Dietary Supplement: phenolics form orange peel |
| phenolics from orange peel, type 2 | Active comparator | 1 dose of 500 mg of phenolics from orange peel, orally ingested Receives: Dietary Supplement: phenolics form orange peel |
| phenolics from orange peel, type 3 | Experimental | 1 dose of 500 mg of phenolics from orange peel, orally ingested Receives: Dietary Supplement: phenolics form orange peel |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma concentrations of specific phenolics and their metabolites
Measured: up to 24 hours
Secondary outcomes (1)
urine concentrations of specific phenolics and their metabolites
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startJul 2013
- Primary completionAug 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Improving BioavailabilityStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chris Van der Grinten, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033330
- Sponsor's protocol ID
- Cordiart-PKA-1
- Status last verified
- Jan 2014
- First submitted
- 9 Jan 2014
- Last updated
- 10 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Bioavailability of Phenolics From an Orange Peel Extract
- ClinicalTrials.gov ID
- NCT02033330
- Acronym / sponsor ID
- Cordiart-PKA-1
- Conditions
- Improving Bioavailability
- Keywords
- phenolics, orange peel, bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 10 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| phenolics form orange peel, type 1 | Active comparator | Dietary Supplement: phenolics form orange peel1 dose of 500 mg of phenolics from orange peel, orally ingested |
| phenolics from orange peel, type 2 | Active comparator | Dietary Supplement: phenolics form orange peel1 dose of 500 mg of phenolics from orange peel, orally ingested |
| phenolics from orange peel, type 3 | Experimental | Dietary Supplement: phenolics form orange peel1 dose of 500 mg of phenolics from orange peel, orally ingested |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy adults
- BMI 18.5 to 25
Key exclusion criteria (6 listed)
- pregnancy
- smoking
- alcohol or drug abuse
- use of medication
- use of nutritional supplements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phenolics form orange peel | Dietary supplement | phenolics form orange peel, type 1, phenolics from orange peel, type 2, phenolics from orange peel, type 3 |
Primary outcome
plasma concentrations of specific phenolics and their metabolites
Time frame: up to 24 hours
1 secondary outcome
urine concentrations of specific phenolics and their metabolites
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Van der Grinten, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phenolics form orange peel in people with Improving Bioavailability, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma concentrations of specific phenolics and their metabolites (time frame: up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2014.