Feeding the Rainbow to Investigate Endothelial Dysfunction (FRIED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01175577
Recruitment Status : Completed
First Posted : August 5, 2010
Last Update Posted : February 3, 2012
University of Washington
Information provided by (Responsible Party):
Ryan David Bradley, 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.

Condition or disease Intervention/treatment 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 Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Evaluating the Effects of Mixed-Carotenoids on Biomarkers of Endothelial Dysfunction
Study Start Date : October 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : August 2011

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change in serum carotenoid fraction concentrations between study arms [ Time Frame: Following 28 day intervention ]

Secondary Outcome Measures :
  1. Change in oxidized LDL lipoproteins (oxLDL) [ Time Frame: Following 28 day intervention ]
  2. Change in serum gamma-glutamyl transferase (GGT) [ Time Frame: Following 28 day intervention ]
  3. Change in urinary isoprostanes [ Time Frame: Following 28 day intervention ]
  4. Change in serum antioxidant capacity (ORAC) [ Time Frame: Following 28 day intervention ]
  5. Change in lipid profile (LDL, HDL, triglycerides) [ Time Frame: Following 28 day intervention ]
  6. Change in C-reactive protein (CRP) [ Time Frame: Following 28 day intervention ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01175577

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
Principal Investigator: Ryan D Bradley, ND, MPH Bastyr University

Responsible Party: Ryan David Bradley, Research Assistant Professor, Bastyr University Identifier: NCT01175577     History of Changes
Other Study ID Numbers: SP
First Posted: August 5, 2010    Key Record Dates
Last Update Posted: February 3, 2012
Last Verified: February 2012

Keywords provided by Ryan David Bradley, Bastyr University:
mixed carotenes

Additional relevant MeSH terms:
Cardiovascular Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs