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

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ClinicalTrials.gov Identifier: NCT01224743

Recruitment Status : Completed

First Posted : October 20, 2010

Last Update Posted : October 20, 2010

Sponsor:

Collaborator:

NSA, LLC

Information provided by:

Griffin Hospital

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Metabolic Syndrome	Dietary Supplement: Blend 1 Dietary Supplement: Blend 2 Dietary Supplement: Placebo	Phase 1 Phase 2

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	64 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Effect of Fruit and Vegetable Concentrates on Endothelial Function in Persons With Metabolic Syndrome: A Randomized, Controlled, Crossover Trial
Study Start Date :	December 2004
Actual Primary Completion Date :	March 2008
Actual Study Completion Date :	March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Metabolic Syndrome

Genetic and Rare Diseases Information Center resources: Abdominal Obesity Metabolic Syndrome

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

Endothelial Function [ Time Frame: 8-weeks ]
Endothelial function as flow-mediated dilatation (FMD)

Secondary Outcome Measures :

Weight [ Time Frame: 8-weeks ]
Measured on a calibrated scale
Lipid panel [ Time Frame: 8-weeks ]
Total cholesterol, TG, HDL, LDL, ratio
Insulin [ Time Frame: 8-weeks ]
Serum insulin

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01224743

Locations


United States, Connecticut
Griffin Hospital
Derby, Connecticut, United States, 06418

Sponsors and Collaborators

Griffin Hospital

NSA, LLC

Investigators


Principal Investigator:	David L Katz, MD, MPH	Yale-Griffin Prevention Research Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ali A, Yazaki Y, Njike VY, Ma Y, Katz DL. Effect of fruit and vegetable concentrates on endothelial function in metabolic syndrome: a randomized controlled trial. Nutr J. 2011 Jun 29;10:72. doi: 10.1186/1475-2891-10-72.


Responsible Party:	David L. Katz, MD, MPH / Director, Yale-Griffin Prevention Research Center
ClinicalTrials.gov Identifier:	NCT01224743 History of Changes
Other Study ID Numbers:	Griffin Hospital IRB #2004-22
First Posted:	October 20, 2010 Key Record Dates
Last Update Posted:	October 20, 2010
Last Verified:	October 2010

Additional relevant MeSH terms:


Syndrome Metabolic Syndrome X Disease Pathologic Processes	Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases

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