NCT00636350

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Sep 2007

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 14, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2010

Completed
Last Updated

October 12, 2017

Status Verified

September 1, 2009

Enrollment Period

2.8 years

First QC Date

March 7, 2008

Last Update Submit

October 11, 2017

Conditions

Healthy

Keywords

pepper carotenoidsxanthophyllshealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • The enrichment of labeled pepper carotenoids in the serum samples after the meals.

    upto 21 days after the start of the study

Interventions

PepperDIETARY_SUPPLEMENT

pepper carotenoids as meals

Also known as: lutein, xanthaphylls

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy volunteers

You may not qualify if:

  • GI track problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tufts University

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Interventions

Lutein

Intervention Hierarchy (Ancestors)

XanthophyllsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 7, 2008

First Posted

March 14, 2008

Study Start

September 1, 2007

Primary Completion

June 30, 2010

Study Completion

June 30, 2010

Last Updated

October 12, 2017

Record last verified: 2009-09

Locations

US(1)