Feeding the Rainbow to Investigate Endothelial Dysfunction (FRIED)

This study has been completed.
Sponsor:
Collaborator:
University of Washington
Information provided by (Responsible Party):
Ryan David Bradley, Bastyr University
ClinicalTrials.gov Identifier:
NCT01175577
First received: August 3, 2010
Last updated: February 2, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Dietary Modification
Cardiovascular Disease
Dietary Supplement: Chlorophyll complex, Standard Process
Dietary Supplement: Betatene, sold as "Full Spectrum Carotenoid Complex"
Other: Small carotenoid-rich meals
Other: Placebo
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Evaluating the Effects of Mixed-Carotenoids on Biomarkers of Endothelial Dysfunction

Resource links provided by NLM:


Further study details as provided by Bastyr University:

Primary Outcome Measures:
  • Change in serum carotenoid fraction concentrations between study arms [ Time Frame: Following 28 day intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in oxidized LDL lipoproteins (oxLDL) [ Time Frame: Following 28 day intervention ] [ Designated as safety issue: No ]
  • Change in serum gamma-glutamyl transferase (GGT) [ Time Frame: Following 28 day intervention ] [ Designated as safety issue: No ]
  • Change in urinary isoprostanes [ Time Frame: Following 28 day intervention ] [ Designated as safety issue: No ]
  • Change in serum antioxidant capacity (ORAC) [ Time Frame: Following 28 day intervention ] [ Designated as safety issue: No ]
  • Change in lipid profile (LDL, HDL, triglycerides) [ Time Frame: Following 28 day intervention ] [ Designated as safety issue: No ]
  • Change in C-reactive protein (CRP) [ Time Frame: Following 28 day intervention ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: October 2009
Study Completion Date: August 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: Placebo Other: Placebo
Safflower oil-filled capsules, one twice daily with meals

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01175577

Locations
United States, Washington
Bastyr University Clinical Research Center
Kenmore, Washington, United States, 98028
University of Washington Clinical Research Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Bastyr University
University of Washington
Investigators
Principal Investigator: Ryan D Bradley, ND, MPH Bastyr University
  More Information

No publications provided

Responsible Party: Ryan David Bradley, Research Assistant Professor, Bastyr University
ClinicalTrials.gov Identifier: NCT01175577     History of Changes
Other Study ID Numbers: SP
Study First Received: August 3, 2010
Last Updated: February 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Bastyr University:
mixed carotenes

Additional relevant MeSH terms:
Cardiovascular Diseases
Carotenoids
Chlorophyllin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents

ClinicalTrials.gov processed this record on August 28, 2014