Effect of Fruit and Vegetable Concentrates on Endothelial Function in Persons With Metabolic Syndrome
Primary Purpose
Metabolic Syndrome
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Blend 1
Blend 2
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Metabolic Syndrome
Eligibility Criteria
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.
Sites / Locations
- Griffin Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
Blend 2
Blend 1
Arm Description
Placebo capsules are provided by the study sponsor and are identical in appearance to active treatments to ensure blinding.
Blend 2 - combination of Juice Plus+® Orchard (Fruit) and Garden (Vegetable) blends
Blend 1 - combination of Juice Plus+® Orchard (Fruit), Garden (Vegetable), and Vineyard (Berry) blends
Outcomes
Primary Outcome Measures
Endothelial Function
Endothelial function as flow-mediated dilatation (FMD)
Secondary Outcome Measures
Weight
Measured on a calibrated scale
Lipid panel
Total cholesterol, TG, HDL, LDL, ratio
Insulin
Serum insulin
Full Information
NCT ID
NCT01224743
First Posted
October 14, 2010
Last Updated
March 25, 2020
Sponsor
Griffin Hospital
Collaborators
NSA, LLC
1. Study Identification
Unique Protocol Identification Number
NCT01224743
Brief Title
Effect of Fruit and Vegetable Concentrates on Endothelial Function in Persons With Metabolic Syndrome
Official Title
Effect of Fruit and Vegetable Concentrates on Endothelial Function in Persons With Metabolic Syndrome: A Randomized, Controlled, Crossover Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Griffin Hospital
Collaborators
NSA, LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules are provided by the study sponsor and are identical in appearance to active treatments to ensure blinding.
Arm Title
Blend 2
Arm Type
Experimental
Arm Description
Blend 2 - combination of Juice Plus+® Orchard (Fruit) and Garden (Vegetable) blends
Arm Title
Blend 1
Arm Type
Experimental
Arm Description
Blend 1 - combination of Juice Plus+® Orchard (Fruit), Garden (Vegetable), and Vineyard (Berry) blends
Intervention Type
Dietary Supplement
Intervention Name(s)
Blend 1
Other Intervention Name(s)
Juice Plus+® Orchard, Garden, Vineyard
Intervention Description
Blend 1 consists of a combination of Juice Plus+® Orchard (Fruit), Garden (Vegetable), and Vineyard (Berry) blends
Intervention Type
Dietary Supplement
Intervention Name(s)
Blend 2
Other Intervention Name(s)
Juice Plus+® Orchard, Garden
Intervention Description
Blend 2 consists of a combination of Juice Plus+® Orchard (Fruit) and Garden (Vegetable) blends
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules are provided by the study sponsor and are identical in appearance to active treatments to ensure blinding.
Primary Outcome Measure Information:
Title
Endothelial Function
Description
Endothelial function as flow-mediated dilatation (FMD)
Time Frame
8-weeks
Secondary Outcome Measure Information:
Title
Weight
Description
Measured on a calibrated scale
Time Frame
8-weeks
Title
Lipid panel
Description
Total cholesterol, TG, HDL, LDL, ratio
Time Frame
8-weeks
Title
Insulin
Description
Serum insulin
Time Frame
8-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David L Katz, MD, MPH
Organizational Affiliation
Yale-Griffin Prevention Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Griffin Hospital
City
Derby
State/Province
Connecticut
ZIP/Postal Code
06418
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21714890
Citation
Ali A, Yazaki Y, Njike VY, Ma Y, Katz DL. Effect of fruit and vegetable concentrates on endothelial function in metabolic syndrome: a randomized controlled trial. Nutr J. 2011 Jun 29;10:72. doi: 10.1186/1475-2891-10-72.
Results Reference
derived
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Effect of Fruit and Vegetable Concentrates on Endothelial Function in Persons With Metabolic Syndrome
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