Effect of Fruit and Vegetable Concentrates on Endothelial Function in Persons With Metabolic Syndrome
This study has been completed.
Sponsor:
Griffin Hospital
Collaborator:
NSA, LLC
Information provided by:
Griffin Hospital
ClinicalTrials.gov Identifier:
NCT01224743
First received: October 14, 2010
Last updated: October 19, 2010
Last verified: October 2010
| Tracking Information | |||||
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| First Received Date ICMJE | October 14, 2010 | ||||
| Last Updated Date | October 19, 2010 | ||||
| Start Date ICMJE | December 2004 | ||||
| Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Endothelial Function [ Time Frame: 8-weeks ] [ Designated as safety issue: No ] Endothelial function as flow-mediated dilatation (FMD) |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01224743 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Fruit and Vegetable Concentrates on Endothelial Function in Persons With Metabolic Syndrome | ||||
| Official Title ICMJE | Effect of Fruit and Vegetable Concentrates on Endothelial Function in Persons With Metabolic Syndrome: A Randomized, Controlled, Crossover Trial | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Metabolic Syndrome | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 64 | ||||
| Completion Date | March 2008 | ||||
| Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01224743 | ||||
| Other Study ID Numbers ICMJE | Griffin Hospital IRB #2004-22 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | David L. Katz, MD, MPH / Director, Yale-Griffin Prevention Research Center | ||||
| Study Sponsor ICMJE | Griffin Hospital | ||||
| Collaborators ICMJE | NSA, LLC | ||||
| Investigators ICMJE |
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| Information Provided By | Griffin Hospital | ||||
| Verification Date | October 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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