Feeding the Rainbow to Investigate Endothelial Dysfunction (FRIED)

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease; Dietary Modification
• Intervention / Treatment: Dietary supplement: Chlorophyll complex, Standard Process; Dietary supplement: Betatene, sold as "Full Spectrum Carotenoid Complex"; Other: Small carotenoid-rich meals; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Washington
    • Kenmore, Washington, United States, 98028
      • Bastyr University Clinical Research Center
    • Seattle, Washington, United States, 98195
      • University of Washington Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Safflower oil-filled capsules, one twice daily with meals
Active Comparator: Supplement 1	Dietary supplement: Chlorophyll complex, Standard Process; One capsule, twice daily with meals for 28 days
Active Comparator: Supplement 2	Dietary supplement: Betatene, sold as "Full Spectrum Carotenoid Complex"; One capsule per day with meals for 28 days
Active Comparator: Food-based Intervention	Other: Small carotenoid-rich meals; Single carotenoid-enriched soup or salad serving eaten daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in serum carotenoid fraction concentrations between study arms	Following 28 day intervention

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bastyr University
• Collaborators: University of Washington
• Investigators: Principal Investigator: Ryan D Bradley, ND, MPH, Bastyr University

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: August 3, 2010
• First Submitted That Met QC Criteria: August 3, 2010
• First Posted (Estimate): August 5, 2010

Study Record Updates

• Last Update Posted (Estimate): February 3, 2012
• Last Update Submitted That Met QC Criteria: February 2, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: mixed carotenes
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Carotenoids
• Other Study ID Numbers: SP