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CompletedNCT01224743Updated Mar 26, 2020

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

A Phase 1/2 interventional study of Blend 1 and Blend 2 in Metabolic Syndrome, sponsored by Griffin Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-26.

Sponsored by Griffin Hospital · Phase 1/2, Interventional, and Prevention

Phase
Phase 1/2
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Metabolic Syndrome
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In context

Metabolic Syndrome

1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.

This study's enrollment of 64 is close to the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

Griffin Hospital is the lead sponsor of 25 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
64 participants (actual)

Study arms

  • 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

  • Experimental
    Blend 2

    Blend 2 - combination of Juice Plus+® Orchard (Fruit) and Garden (Vegetable) blends

    Dietary Supplement: Blend 2

  • Experimental
    Blend 1

    Blend 1 - combination of Juice Plus+® Orchard (Fruit), Garden (Vegetable), and Vineyard (Berry) blends

    Dietary Supplement: Blend 1

Interventions

  • Dietary supplementBlend 1

    Blend 1 consists of a combination of Juice Plus+® Orchard (Fruit), Garden (Vegetable), and Vineyard (Berry) blends

    Also known as: Juice Plus+® Orchard, Garden, Vineyard

  • Dietary supplementBlend 2

    Blend 2 consists of a combination of Juice Plus+® Orchard (Fruit) and Garden (Vegetable) blends

    Also known as: Juice Plus+® Orchard, Garden

  • Dietary supplementPlacebo

    Placebo capsules are provided by the study sponsor and are identical in appearance to active treatments to ensure blinding.

06

What researchers measure

Primary outcomes

  1. Endothelial Function

    Endothelial function as flow-mediated dilatation (FMD)

    Time frame: 8-weeks

Secondary outcomes

  1. Weight

    Measured on a calibrated scale

    Time frame: 8-weeks

  2. Lipid panel

    Total cholesterol, TG, HDL, LDL, ratio

    Time frame: 8-weeks

  3. Insulin

    Serum insulin

    Time frame: 8-weeks

07

Study locations

1 site
  • Griffin Hospital
    Derby, Connecticut 06418, United States
08

References and documents

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. PubMed 21714890 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01224743
Lead sponsor
Griffin Hospital
Collaborators
NSA, LLC
First posted
Oct 20, 2010
Start date
Dec 2004
Primary completion
Mar 2008
Completion
Mar 2008
Last update
Mar 26, 2020

Study contacts

David L Katz, MD, MPH
principal investigator · Yale-Griffin Prevention Research Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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