Feeding the Rainbow to Investigate Endothelial Dysfunction (FRIED)

Bastyr University

Status and phase: Completed; Early Phase 1

Conditions: Dietary Modification; Cardiovascular Disease

Treatments: Dietary Supplement: Betatene, sold as "Full Spectrum Carotenoid Complex"; Other: Placebo; Dietary Supplement: Chlorophyll complex, Standard Process; Other: Small carotenoid-rich meals

Study type: Interventional

Funder types: Other

Identifiers

NCT01175577

SP

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 4 patient groups, including a placebo group

Supplement 1

Active Comparator group

Treatment:

Dietary Supplement: Chlorophyll complex, Standard Process

Supplement 2

Active Comparator group

Treatment:

Dietary Supplement: Betatene, sold as "Full Spectrum Carotenoid Complex"

Food-based Intervention

Active Comparator group

Treatment:

Other: Small carotenoid-rich meals

Placebo

Placebo Comparator group

Treatment:

Other: Placebo