NCT01175577

Feeding the Rainbow to Investigate Endothelial Dysfunction

Evaluating the Effects of Mixed-Carotenoids on Biomarkers of Endothelial Dysfunction

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Bastyr University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

• Dietary Modification
• Cardiovascular Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-06-01
• Completion: 2011-08-01
• First posted: 2010-08-05
• Last updated: 2012-02-03

Locations

2 sites across 1 country: United States