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

Griffin Hospital

Status and phase: Completed; Phase 2; Phase 1

Conditions: Metabolic Syndrome

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Blend 2; Dietary Supplement: Blend 1

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01224743

2004-22

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo

Blend 2

Experimental group

Description:

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

Treatment:

Dietary Supplement: Blend 2

Blend 1

Experimental group

Description:

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

Treatment:

Dietary Supplement: Blend 1