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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

Tracking Information
First Submitted Date  ICMJE October 14, 2010
First Posted Date  ICMJE October 20, 2010
Last Update Posted Date October 20, 2010
Study Start Date  ICMJE December 2004
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2010)
Endothelial Function [ Time Frame: 8-weeks ]
Endothelial function as flow-mediated dilatation (FMD)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2010)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Fruit and Vegetable Concentrates on Endothelial Function in Persons With Metabolic Syndrome
Official Title  ICMJE Effect of Fruit and Vegetable Concentrates on Endothelial Function in Persons With Metabolic Syndrome: A Randomized, Controlled, Crossover Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Metabolic Syndrome
Intervention  ICMJE
  • 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
  • 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
  • Dietary Supplement: Placebo
    Placebo capsules are provided by the study sponsor and are identical in appearance to active treatments to ensure blinding.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo capsules are provided by the study sponsor and are identical in appearance to active treatments to ensure blinding.
    Intervention: Dietary Supplement: Placebo
  • Experimental: Blend 2
    Blend 2 - combination of Juice Plus+® Orchard (Fruit) and Garden (Vegetable) blends
    Intervention: Dietary Supplement: Blend 2
  • Experimental: Blend 1
    Blend 1 - combination of Juice Plus+® Orchard (Fruit), Garden (Vegetable), and Vineyard (Berry) blends
    Intervention: Dietary Supplement: Blend 1
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 19, 2010)
64
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01224743
Other Study ID Numbers  ICMJE Griffin Hospital IRB #2004-22
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David L. Katz, MD, MPH / Director, Yale-Griffin Prevention Research Center
Study Sponsor  ICMJE Griffin Hospital
Collaborators  ICMJE NSA, LLC
Investigators  ICMJE
Principal Investigator: David L Katz, MD, MPH Yale-Griffin Prevention Research Center
PRS Account Griffin Hospital
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP