Feeding the Rainbow to Investigate Endothelial Dysfunction

Early Phase 1

Completed

• Conditions: Cardiovascular Disease; Dietary Modification
• Interventions: Other: Placebo; Dietary Supplement: Chlorophyll complex, Standard Process; Dietary Supplement: Betatene, sold as "Full Spectrum Carotenoid Complex"; Other: Small carotenoid-rich meals

• Registration Number: NCT01175577
• Lead Sponsor: Bastyr University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-08-03
• Study First Submitted QC: 2010-08-03
• Study First Posted: 2010-08-05
• Primary Completion: 2011-06
• Study Completion: 2011-08
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-02
• Last Update Posted: 2012-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• adults aged 18-65
• in good health by the absence of exclusion criteria on standardized medical history interview
• willingness to be randomized
• willingness to complete multiple blood draws following fast food consumption on two occasions over 28 days

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Exclusion Criteria

• children <18 years
• current use of carotenoid supplements (not including typical multivitamins containing beta-carotene)
• current use of polyphenol supplements including green tea, resveratrol, pine bark extract, cocoa, and/or grape skin extract
• current use of aspirin, statins or regular (>2 per week) use of NSAID medications
• current smoking or past smoking greater than 3 packs total or currently living with a smoker
• excessive alcohol intake (> 3 drinks per day) or history of alcoholism
• known exposure to asbestos
• autoimmune disease
• hemachromatosis
• history of gallbladder disease including gall stones or gall bladder removal
• pre-diabetes, metabolic syndrome or diabetes (1 or 2)
• established cardiovascular disease (arrhythmia, heart failure, hypertension treatment or untreated stage II hypertension (≥160/90; stage II technically diastolic ≥100mmHg, will maintain diastolic cutoff of 90mmHg), past MI or stroke)
• renal or liver disease (viral hepatitis, non-alcoholic steatohepatitis "fatty liver")
• acute infection except viral colds
• residual injury/pain/limitation from trauma
• chronic musculoskeletal disorders including osteoarthritis requiring pain medications
• psychiatric disorders that would impair completion of research tasks
• allergies to supplied foods
• anyone on a medically-prescribed diet
• >3.5 servings fruits/veggies per day
• inability to consume entire study Control meal w/in specified timeline (30 minutes)
• current pregnancy or breast feeding
• refusal to participate in blood draws following the control meal.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Supplement 1	Chlorophyll complex, Standard Process	-
Supplement 2	Betatene, sold as "Full Spectrum Carotenoid Complex"	-
Food-based Intervention	Small carotenoid-rich meals	-

Primary Outcome Measures

Name	Time	Method
Change in serum carotenoid fraction concentrations between study arms	Following 28 day intervention

Secondary Outcome Measures

Name	Time	Method
Change in serum antioxidant capacity (ORAC)	Following 28 day intervention
Change in lipid profile (LDL, HDL, triglycerides)	Following 28 day intervention
Change in oxidized LDL lipoproteins (oxLDL)	Following 28 day intervention
Change in serum gamma-glutamyl transferase (GGT)	Following 28 day intervention
Change in C-reactive protein (CRP)	Following 28 day intervention
Change in urinary isoprostanes	Following 28 day intervention

Trial Locations

Locations (2)

University of Washington Clinical Research Center; 🇺🇸 Seattle, Washington, United States

Bastyr University Clinical Research Center; 🇺🇸 Kenmore, Washington, United States