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
  Purpose

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 Intervention Phase
Metabolic Syndrome
Dietary Supplement: Blend 1
Dietary Supplement: Blend 2
Dietary Supplement: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Griffin Hospital:

Primary Outcome Measures:
  • Endothelial Function [ Time Frame: 8-weeks ] [ Designated as safety issue: No ]
    Endothelial function as flow-mediated dilatation (FMD)


Secondary Outcome Measures:
  • 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


Enrollment: 64
Study Start Date: December 2004
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Griffin Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Study First Received: October 14, 2010
Last Updated: October 19, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 20, 2014