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

NCT ID: NCT01224743

Last Updated: 2020-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2008-03-31

Brief Summary

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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

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Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Blend 2

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

Group Type EXPERIMENTAL

Blend 2

Intervention Type DIETARY_SUPPLEMENT

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

Blend 1

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

Group Type EXPERIMENTAL

Blend 1

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Blend 1

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

Intervention Type DIETARY_SUPPLEMENT

Blend 2

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Juice Plus+® Orchard, Garden, Vineyard Juice Plus+® Orchard, Garden

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NSA, LLC

INDUSTRY

Sponsor Role collaborator

Griffin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yale-Griffin Prevention Research Center

Principal Investigators

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David L Katz, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Yale-Griffin Prevention Research Center

Locations

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Griffin Hospital

Derby, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 21714890 (View on PubMed)

Other Identifiers

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2004-22

Identifier Type: -

Identifier Source: org_study_id

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