Feeding the Rainbow to Investigate Endothelial Dysfunction

Cardiovascular Disease Clinical Trial

— FRIED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01175577
• Other study ID #: SP
• Status: Completed
• Phase: Phase 0
• First received: August 3, 2010
• Last updated: February 2, 2012
• Start date: October 2009
• Est. completion date: August 2011

Study information

• Verified date: February 2012
• Source: Bastyr University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Dietary Modification

Intervention

Dietary Supplement:
• Chlorophyll complex, Standard Process
One capsule, twice daily with meals for 28 days
• Betatene, sold as "Full Spectrum Carotenoid Complex"
One capsule per day with meals for 28 days

Other:
• Small carotenoid-rich meals
Single carotenoid-enriched soup or salad serving eaten daily
• Placebo
Safflower oil-filled capsules, one twice daily with meals

Locations

Country	Name	City	State
United States	Bastyr University Clinical Research Center	Kenmore	Washington
United States	University of Washington Clinical Research Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Bastyr University	University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum carotenoid fraction concentrations between study arms		Following 28 day intervention	No
Secondary	Change in oxidized LDL lipoproteins (oxLDL)		Following 28 day intervention	No
Secondary	Change in serum gamma-glutamyl transferase (GGT)		Following 28 day intervention	No
Secondary	Change in urinary isoprostanes		Following 28 day intervention	No
Secondary	Change in serum antioxidant capacity (ORAC)		Following 28 day intervention	No
Secondary	Change in lipid profile (LDL, HDL, triglycerides)		Following 28 day intervention	No
Secondary	Change in C-reactive protein (CRP)		Following 28 day intervention	No