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OpenTrials
Completed

NCT Number: NCT01175577

Feeding the Rainbow to Investigate 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Bastyr University Clinical Research Center, Kenmore, Washington, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chlorophyll complex, Standard Process

Dietary Supplement

One capsule, twice daily with meals for 28 days

Betatene, sold as "Full Spectrum Carotenoid Complex"

Dietary Supplement

One capsule per day with meals for 28 days

Small carotenoid-rich meals

Other

Single carotenoid-enriched soup or salad serving eaten daily

Placebo

Other

Safflower oil-filled capsules, one twice daily with meals

Primary outcomes

  1. Change in serum carotenoid fraction concentrations between study arms

    Time frame: Following 28 day intervention

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bastyr University

Other

Collaborators

  • University of Washington

Registry information

Official study title

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

Acronym: FRIED

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 5, 2010
Registry last updated
Feb 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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