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

Phase 1

Completed

• Conditions: Metabolic Syndrome
• Interventions: Dietary Supplement: Blend 2; Dietary Supplement: Placebo; Dietary Supplement: Blend 1

• Registration Number: NCT01224743
• Lead Sponsor: Griffin Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Study First Submitted: 2010-10-14
• Study First Submitted QC: 2010-10-19
• Study First Posted: 2010-10-20
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-25
• Last Update Posted: 2020-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blend 2	Blend 2	Blend 2 - combination of Juice Plus+® Orchard (Fruit) and Garden (Vegetable) blends
Placebo	Placebo	Placebo capsules are provided by the study sponsor and are identical in appearance to active treatments to ensure blinding.
Blend 1	Blend 1	Blend 1 - combination of Juice Plus+® Orchard (Fruit), Garden (Vegetable), and Vineyard (Berry) blends

Primary Outcome Measures

Name	Time	Method
Endothelial Function	8-weeks	Endothelial function as flow-mediated dilatation (FMD)

Secondary Outcome Measures

Name	Time	Method
Weight	8-weeks	Measured on a calibrated scale
Lipid panel	8-weeks	Total cholesterol, TG, HDL, LDL, ratio
Insulin	8-weeks	Serum insulin

Trial Locations

Locations (1)

Griffin Hospital; 🇺🇸 Derby, Connecticut, United States