Flavonoid Supplementation and Endothelial Function
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00331227 |
Recruitment Status :
Completed
First Posted : May 29, 2006
Last Update Posted : March 15, 2007
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Flavonoids are one of the many classes of natural chemicals found in a variety of foods. People with the highest flavonoid blood levels have the lowest rates of coronary heart disease. This is considered one of the reasons why high fruit and vegetable consumption is associated with lower rates of heart disease, although it is not known if taking a flavonoid supplement provides the same protection as eating fruits and vegetables.
The purpose of this study is to determine if a particular flavonoid supplement, called Isotonix OPC-3, taken on a daily basis, will improve the function of arterial vessels. Arteries normally constrict after eating a high-fat meal. This study will examine the potential of the OPC-3 to lessen this constriction response. Approximately 25 people will be involved in this research project and participation will last for 10 weeks.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: Isotonix OPC-3 (flavonoid supplement) | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 25 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double |
Primary Purpose: | Prevention |
Official Title: | Effect of Supplemental Flavonoids on Endothelial Function, Lipids, and Markers of Inflammation |
Study Start Date : | May 2006 |
Study Completion Date : | December 2006 |
- Change in endothelial function from baseline
- CRP
- Lipid profile
- Lp-PLA2

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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:
- 18 yrs of age or older
- no pregnant potential
Exclusion Criteria:
- History of coronary artery disease
- History of cerebrovascular disease
- History of heart failure
- Diabetes
- Renal impairment
- Uncontrolled hypertension
- Untreated or clinically evident thyroid disease
- Currently taking medications or supplements with known or potential lipid-altering effects including: phytosterols, statins, cholestin, niacin, fibrates, psyllium fiber, bile acid sequestrants, diabetic medications, and weight control medications such as orlistat
- Pregnancy or breastfeeding
- Tobacco use - Participants will be excluded with a history of smoking anytime in the past 6 months.
- Inappropriate for participation in a study, if in the opinion of the investigator it is questionable whether the participant will be able to comply with all aspects of the protocol (e.g. inadequate cognitive skills, possible drug abuse or dependence, suspected psychiatric problems, etc.)

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): NCT00331227
Principal Investigator: | Thomas Barringer, MD | Carolinas Medical Center |
ClinicalTrials.gov Identifier: | NCT00331227 |
Other Study ID Numbers: |
202021 |
First Posted: | May 29, 2006 Key Record Dates |
Last Update Posted: | March 15, 2007 |
Last Verified: | March 2007 |
flavonoids food supplements endothelial function no conditions allowed, healthy volunteers only |