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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01224743
• Other study ID #: 2004-22
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 2004
• Est. completion date: March 2008

Study information

• Verified date: March 2020
• Source: Griffin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Blend 1
Blend 1 consists of a combination of Juice Plus+® Orchard (Fruit), Garden (Vegetable), and Vineyard (Berry) blends
• Blend 2
Blend 2 consists of a combination of Juice Plus+® Orchard (Fruit) and Garden (Vegetable) blends
• Placebo
Placebo capsules are provided by the study sponsor and are identical in appearance to active treatments to ensure blinding.

Locations

Country	Name	City	State
United States	Griffin Hospital	Derby	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Griffin Hospital	NSA, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial Function	Endothelial function as flow-mediated dilatation (FMD)	8-weeks
Secondary	Weight	Measured on a calibrated scale	8-weeks
Secondary	Lipid panel	Total cholesterol, TG, HDL, LDL, ratio	8-weeks
Secondary	Insulin	Serum insulin	8-weeks