Effect of Fruit and Vegetable Concentrates on Endothelial Function in Persons With Metabolic Syndrome
Phase 1
Completed
- Conditions
- Metabolic Syndrome
- 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
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
- 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
Griffin Hospital🇺🇸Derby, Connecticut, United States