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Feeding the Rainbow to Investigate Endothelial Dysfunction

NCT01175577 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2012-02-03

No results posted yet for this study

Summary

The primary purpose of this study is to compare the change in blood carotene concentration between a food-based versus nutritional supplement-based intervention. This study will randomize up to 60 healthy volunteers to receive either carotenoid-enriched food; natural, mixed carotenoid supplementation; chlorophyll complex or placebo supplementation. Blood carotene levels will be measured before and after 28 days of supplementation. Preliminary data will also be collected on several biomarkers associated with vascular inflammation and endothelial dysfunction. These biomarkers will be measured before and during a fast food control meal at the beginning and end of the intervention period.

Conditions

Interventions

DIETARY_SUPPLEMENT

Chlorophyll complex, Standard Process

One capsule, twice daily with meals for 28 days

DIETARY_SUPPLEMENT

Betatene, sold as "Full Spectrum Carotenoid Complex"

One capsule per day with meals for 28 days

OTHER

Small carotenoid-rich meals

Single carotenoid-enriched soup or salad serving eaten daily

OTHER

Placebo

Safflower oil-filled capsules, one twice daily with meals

Sponsors & Collaborators

Principal Investigators

  • Ryan D Bradley, ND, MPH · Bastyr University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2011-06-30
Completion
2011-08-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01175577 on ClinicalTrials.gov