Effect of Fruit and Vegetable Concentrates on Endothelial Function in Persons With Metabolic Syndrome

Study Overview
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Brief Summary
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Dehydrated fruit and vegetable concentrates provide an accessible form of phytonutrient supplementation that may offer cardioprotective effects. This study assessed the effects of encapsulated fruit and vegetable juice powder concentrates on endothelial function and cardiac risk markers in subjects in a randomized, double blind, placebo controlled crossover clinical trial with three treatment arms.

Official Title
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Effect of Fruit and Vegetable Concentrates on Endothelial Function in Persons With Metabolic Syndrome: A Randomized, Controlled, Crossover Trial

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: Blend 1
* Dietary Supplement: Blend 2
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: metabolic syndrome defined by AHA/NHLBI criteria nonsmoker not taking any other vitamins or dietary supplements able to have blood pressure measured bilaterally at the brachial artery Exclusion Criteria: any unstable medical condition that would limit the ability to participate fully in the trial rheumatologic disease requiring regular use of NSAIDs preexisting cardiovascular disease diagnosed eating disorder inability to complete endothelial function assessment. use of insulin, glucose sensitizing medication, vasoactive medications (including glucocorticoids, antineoplastic agents, psychoactive agents, or bronchodilators), nutriceuticals, fiber supplements, and tobacco.

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo capsules are provided by the study sponsor and are identical in appearance to active treatments to ensure blinding. | Dietary Supplement: Placebo<br>* Placebo capsules are provided by the study sponsor and are identical in appearance to active treatments to ensure blinding.<br>|
| Experimental: Blend 2<br>Blend 2 - combination of Juice Plus+® Orchard (Fruit) and Garden (Vegetable) blends | Dietary Supplement: Blend 2<br>* Blend 2 consists of a combination of Juice Plus+® Orchard (Fruit) and Garden (Vegetable) blends<br>* Other names: Juice Plus+® Orchard, Garden;|
| Experimental: Blend 1<br>Blend 1 - combination of Juice Plus+® Orchard (Fruit), Garden (Vegetable), and Vineyard (Berry) blends | Dietary Supplement: Blend 1<br>* Blend 1 consists of a combination of Juice Plus+® Orchard (Fruit), Garden (Vegetable), and Vineyard (Berry) blends<br>* Other names: Juice Plus+® Orchard, Garden, Vineyard;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial Function | Endothelial function as flow-mediated dilatation (FMD) | 8-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Measured on a calibrated scale | 8-weeks | 
| Lipid panel | Total cholesterol, TG, HDL, LDL, ratio | 8-weeks | 
| Insulin | Serum insulin | 8-weeks |