Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Endothelial Function [ Time Frame: 8-weeks ]
    Endothelial function as flow-mediated dilatation (FMD)


Secondary Outcome Measures :
  1. Weight [ Time Frame: 8-weeks ]
    Measured on a calibrated scale

  2. Lipid panel [ Time Frame: 8-weeks ]
    Total cholesterol, TG, HDL, LDL, ratio

  3. Insulin [ Time Frame: 8-weeks ]
    Serum insulin


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
United States, Connecticut
Griffin Hospital
Derby, Connecticut, United States, 06418
Sponsors and Collaborators
Griffin Hospital
NSA, LLC
Investigators
Layout table for investigator information
Principal Investigator: David L Katz, MD, MPH Yale-Griffin Prevention Research Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Layout table for additonal information
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:
Layout table for MeSH terms
Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
 Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases