Feeding the Rainbow to Investigate Endothelial Dysfunction

Study Overview
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Brief Summary
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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.

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

Conditions
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Dietary Modification, Cardiovascular Disease

Intervention / Treatment
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* Dietary Supplement: Chlorophyll complex, Standard Process
* Dietary Supplement: Betatene, sold as Full Spectrum Carotenoid Complex
* Other: Small carotenoid-rich meals
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Supplement 1<br> | Dietary Supplement: Chlorophyll complex, Standard Process<br>* One capsule, twice daily with meals for 28 days<br>|
| Active Comparator: Supplement 2<br> | Dietary Supplement: Betatene, sold as Full Spectrum Carotenoid Complex<br>* One capsule per day with meals for 28 days<br>|
| Active Comparator: Food-based Intervention<br> | Other: Small carotenoid-rich meals<br>* Single carotenoid-enriched soup or salad serving eaten daily<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Safflower oil-filled capsules, one twice daily with meals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum carotenoid fraction concentrations between study arms |  | Following 28 day intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in oxidized LDL lipoproteins (oxLDL) |  | Following 28 day intervention | 
| Change in serum gamma-glutamyl transferase (GGT) |  | Following 28 day intervention | 
| Change in urinary isoprostanes |  | Following 28 day intervention | 
| Change in serum antioxidant capacity (ORAC) |  | Following 28 day intervention | 
| Change in lipid profile (LDL, HDL, triglycerides) |  | Following 28 day intervention | 
| Change in C-reactive protein (CRP) |  | Following 28 day intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mixed carotenes