HealthyPhase 1NCT00636350
Bioavailability of Pepper Carotenoids in Humans
A Phase 1 study testing Pepper in people with Healthy, run by Tufts University at 1 site in United States.
Trial summary
list item one, Peppers We propose to evaluate bio absorption of pepper carotenoids in a red bell-pepper or non-pungent green jalapeno pepper. The pepper will be provided in a cooked dish. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pepper
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to 30 Jun 2010
- Phase
- Phase 1
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteers
Who cannot join
- GI track problems
Trial locations and contacts
1 site in 1 country.
About this study
- list item one, Peppers
We propose to evaluate bio absorption of pepper carotenoids in a red bell-pepper or non-pungent green jalapeno pepper. The pepper will be provided in a cooked dish. The specific aims of this study are: 1) to determine blood response kinetics of lutein following multiple doses of non-pungent green jalapeno pepper with meals. 2) to determine blood response kinetics of zeaxanthin/capsanthin following multiple doses of red bell pepper with meals. We will feed 16 healthy man and women (50 - 65 y, females were at least one year post menopause), each cooked green jalapeno pepper or red pepper for 4 days and donate blood samples up to 21 days to determine blood response kinetics of xanthophylls following multiple doses of pepper dishes.
Read the detailed description
- list item one, Peppers
Epidemiological data show that carotenoids and ß-C are health promoting when taken at physiologic levels in foods. However, human absorption and metabolism of carotenoids contained in various food matrices has not been studied well. It is important to investigate the characteristics of absorption and disposal kinetics after eating carotenoid rich foods in order to gain a basic understanding of the biological characteristics of lutein, zeaxanthin, and other carotenoids in food sources.
We propose to evaluate bio absorption of pepper carotenoids in a 2-phase research study: phase 1 will utilize red bell-pepper and phase 2 will utilize non-pungent green jalapeno pepper. The pepper will be provided as a dish in a meal. We will feed 16 healthy man and women (50 - 70 y, females were at least one year post menopause), each with red pepper (phase 1) and/or green jalapeno pepper (phase 2) for ~ 4 days and donate blood samples up to 21 days. Volunteers will be randomly assigned to one of the following two phases: phase 1 and phase 2.
The study will provide us the information on the bioavailability of pepper carotenoids.
- Conditions
- Healthy
- Being tested
- Pepper
- Keywords
- pepper carotenoids, xanthophylls, healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PepperDietary supplement
Also called lutein, xanthaphylls
pepper carotenoids as meals
What is being measured
The primary outcome is the main question the study is designed to answer.
The enrichment of labeled pepper carotenoids in the serum samples after the meals.
Measured: upto 21 days after the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startSep 2007
- Primary completion30 Jun 2010
- Study completion30 Jun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636350
- Sponsor's protocol ID
- 58-1950-7-707
- Status last verified
- Sep 2009
- First submitted
- 7 Mar 2008
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Pepper Carotenoids in Humans
- ClinicalTrials.gov ID
- NCT00636350
- Acronym / sponsor ID
- 58-1950-7-707
- Conditions
- Healthy
- Keywords
- pepper carotenoids, xanthophylls, healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- 30 Jun 2010 (actual)
- Study completion
- 30 Jun 2010 (actual)
- First posted
- 14 Mar 2008 (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.
- list item one, Peppers
We propose to evaluate bio absorption of pepper carotenoids in a red bell-pepper or non-pungent green jalapeno pepper. The pepper will be provided in a cooked dish. The specific aims of this study are: 1) to determine blood response kinetics of lutein following multiple doses of non-pungent green jalapeno pepper with meals. 2) to determine blood response kinetics of zeaxanthin/capsanthin following multiple doses of red bell pepper with meals. We will feed 16 healthy man and women (50 - 65 y, females were at least one year post menopause), each cooked green jalapeno pepper or red pepper for 4 days and donate blood samples up to 21 days to determine blood response kinetics of xanthophylls following multiple doses of pepper dishes.
Detailed description
- list item one, Peppers
Epidemiological data show that carotenoids and ß-C are health promoting when taken at physiologic levels in foods. However, human absorption and metabolism of carotenoids contained in various food matrices has not been studied well. It is important to investigate the characteristics of absorption and disposal kinetics after eating carotenoid rich foods in order to gain a basic understanding of the biological characteristics of lutein, zeaxanthin, and other carotenoids in food sources.
We propose to evaluate bio absorption of pepper carotenoids in a 2-phase research study: phase 1 will utilize red bell-pepper and phase 2 will utilize non-pungent green jalapeno pepper. The pepper will be provided as a dish in a meal. We will feed 16 healthy man and women (50 - 70 y, females were at least one year post menopause), each with red pepper (phase 1) and/or green jalapeno pepper (phase 2) for ~ 4 days and donate blood samples up to 21 days. Volunteers will be randomly assigned to one of the following two phases: phase 1 and phase 2.
The study will provide us the information on the bioavailability of pepper carotenoids.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy volunteers
Key exclusion criteria (1 listed)
- GI track problems
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 |
|---|---|---|
| PepperAlso: lutein, xanthaphyllspepper carotenoids as meals | Dietary supplement | – |
Primary outcome
The enrichment of labeled pepper carotenoids in the serum samples after the meals.
Time frame: upto 21 days after the start of the study
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 12 Oct 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pepper in people with Healthy, run by Tufts University at 1 site in United States.
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 1 inclusion and 1 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 12 Oct 2017. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The enrichment of labeled pepper carotenoids in the serum samples after the meals. (time frame: upto 21 days after the start of the study). 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 12 Oct 2017.