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

This study has been completed.
Sponsor:
Collaborator:
NSA, LLC
Information provided by:
Griffin Hospital
ClinicalTrials.gov Identifier:
NCT01224743
First received: October 14, 2010
Last updated: October 19, 2010
Last verified: October 2010

October 14, 2010
October 19, 2010
December 2004
March 2008   (final data collection date for primary outcome measure)
Endothelial Function [ Time Frame: 8-weeks ] [ Designated as safety issue: No ]
Endothelial function as flow-mediated dilatation (FMD)
Same as current
Complete list of historical versions of study NCT01224743 on ClinicalTrials.gov Archive Site
  • Weight [ Time Frame: 8-weeks ] [ Designated as safety issue: No ]
    Measured on a calibrated scale
  • Lipid panel [ Time Frame: 8-weeks ] [ Designated as safety issue: No ]
    Total cholesterol, TG, HDL, LDL, ratio
  • Insulin [ Time Frame: 8-weeks ] [ Designated as safety issue: No ]
    Serum insulin
Same as current
Not Provided
Not Provided
 
Effect of Fruit and Vegetable Concentrates on Endothelial Function in Persons With Metabolic Syndrome
Effect of Fruit and Vegetable Concentrates on Endothelial Function in Persons With Metabolic Syndrome: A Randomized, Controlled, Crossover Trial

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Metabolic Syndrome
  • 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.
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
March 2008
March 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01224743
Griffin Hospital IRB #2004-22
No
David L. Katz, MD, MPH / Director, Yale-Griffin Prevention Research Center
Griffin Hospital
NSA, LLC
Principal Investigator: David L Katz, MD, MPH Yale-Griffin Prevention Research Center
Griffin Hospital
October 2010

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