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OpenTrials
Completed

NCT Number: NCT01224743

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

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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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Griffin Hospital

Derby, Connecticut, 06418, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blend 1

Dietary Supplement

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

Other names: Juice Plus+® Orchard, Garden, Vineyard

Blend 2

Dietary Supplement

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

Other names: Juice Plus+® Orchard, Garden

Placebo

Dietary Supplement

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

Primary outcomes

  1. Endothelial Function

    Time frame: 8-weeks

    Endothelial function as flow-mediated dilatation (FMD)

Secondary outcomes

  1. Weight

    Time frame: 8-weeks

    Measured on a calibrated scale

  2. Lipid panel

    Time frame: 8-weeks

    Total cholesterol, TG, HDL, LDL, ratio

  3. Insulin

    Time frame: 8-weeks

    Serum insulin

Sponsors and collaborators

Lead sponsor

Griffin Hospital

Other

Collaborators

  • NSA, LLC

Registry information

Official study title

Effect of Fruit and Vegetable Concentrates on Endothelial Function in Persons With Metabolic Syndrome: A Randomized, Controlled, Crossover Trial

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Oct 20, 2010
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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