Effect of Fruit and Vegetable Concentrates on Endothelial Function in Persons With Metabolic Syndrome
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ClinicalTrials.gov Identifier: NCT01224743 |
Recruitment Status :
Completed
First Posted : October 20, 2010
Last Update Posted : March 26, 2020
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Condition or disease | Intervention/treatment | Phase |
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Metabolic Syndrome | Dietary Supplement: Blend 1 Dietary Supplement: Blend 2 Dietary Supplement: Placebo | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 64 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Effect of Fruit and Vegetable Concentrates on Endothelial Function in Persons With Metabolic Syndrome: A Randomized, Controlled, Crossover Trial |
Study Start Date : | December 2004 |
Actual Primary Completion Date : | March 2008 |
Actual Study Completion Date : | March 2008 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Placebo capsules are provided by the study sponsor and are identical in appearance to active treatments to ensure blinding.
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Dietary Supplement: Placebo
Placebo capsules are provided by the study sponsor and are identical in appearance to active treatments to ensure blinding. |
Experimental: Blend 2
Blend 2 - combination of Juice Plus+® Orchard (Fruit) and Garden (Vegetable) blends
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Dietary Supplement: Blend 2
Blend 2 consists of a combination of Juice Plus+® Orchard (Fruit) and Garden (Vegetable) blends
Other Name: Juice Plus+® Orchard, Garden |
Experimental: Blend 1
Blend 1 - combination of Juice Plus+® Orchard (Fruit), Garden (Vegetable), and Vineyard (Berry) blends
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Dietary Supplement: Blend 1
Blend 1 consists of a combination of Juice Plus+® Orchard (Fruit), Garden (Vegetable), and Vineyard (Berry) blends
Other Name: Juice Plus+® Orchard, Garden, Vineyard |
- Endothelial Function [ Time Frame: 8-weeks ]Endothelial function as flow-mediated dilatation (FMD)
- Weight [ Time Frame: 8-weeks ]Measured on a calibrated scale
- Lipid panel [ Time Frame: 8-weeks ]Total cholesterol, TG, HDL, LDL, ratio
- Insulin [ Time Frame: 8-weeks ]Serum insulin

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01224743
United States, Connecticut | |
Griffin Hospital | |
Derby, Connecticut, United States, 06418 |
Principal Investigator: | David L Katz, MD, MPH | Yale-Griffin Prevention Research Center |
Responsible Party: | David L. Katz, MD, MPH / Director, Yale-Griffin Prevention Research Center |
ClinicalTrials.gov Identifier: | NCT01224743 |
Other Study ID Numbers: |
2004-22 |
First Posted: | October 20, 2010 Key Record Dates |
Last Update Posted: | March 26, 2020 |
Last Verified: | March 2020 |
Metabolic Syndrome Syndrome Disease Pathologic Processes |
Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |