Clinical trial NCT01175577: Feeding the Rainbow to Investigate Endothelial Dysfunction
Official title: Evaluating the Effects of Mixed-Carotenoids on Biomarkers of Endothelial Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Dietary Modification
Cardiovascular Disease
Keywords: mixed carotenes
Lead sponsor: Bastyr University
Sponsor class: OTHER
Collaborators: name: University of Washington
First posted: 2010-08-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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.

Primary outcomes:
measure: Change in serum carotenoid fraction concentrations between study arms
timeFrame: Following 28 day intervention
Secondary outcomes:
measure: Change in oxidized LDL lipoproteins (oxLDL)
timeFrame: Following 28 day intervention
measure: Change in serum gamma-glutamyl transferase (GGT)
timeFrame: Following 28 day intervention
measure: Change in urinary isoprostanes
timeFrame: Following 28 day intervention
measure: Change in serum antioxidant capacity (ORAC)
timeFrame: Following 28 day intervention
measure: Change in lipid profile (LDL, HDL, triglycerides)
timeFrame: Following 28 day intervention
measure: Change in C-reactive protein (CRP)
timeFrame: Following 28 day intervention
Other outcomes:
Locations:
city: Kenmore
country: United States
facility: Bastyr University Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: University of Washington Clinical Research Center
state: Washington
Study officials:
affiliation: Bastyr University
name: Ryan D Bradley, ND, MPH
role: PRINCIPAL_INVESTIGATOR
References: