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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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01224743
Enrollment
64
Registered
2010-10-20
Start date
2004-12-31
Completion date
2008-03-31
Last updated
2020-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

Brief 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.

Interventions

DIETARY_SUPPLEMENTBlend 1

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

DIETARY_SUPPLEMENTBlend 2

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

DIETARY_SUPPLEMENTPlacebo

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

Sponsors

NSA, LLC
CollaboratorINDUSTRY
Griffin Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Endothelial Function8-weeksEndothelial function as flow-mediated dilatation (FMD)

Secondary

MeasureTime frameDescription
Weight8-weeksMeasured on a calibrated scale
Lipid panel8-weeksTotal cholesterol, TG, HDL, LDL, ratio
Insulin8-weeksSerum insulin

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026