Flavonoid Supplementation and Endothelial Function
キーワード
概要
説明
We propose to use a supplement made by NutraMetrix (called OPC-3), consisting of oligomeric proanthocyanidins derived from grape seed, pine bark, bilberry, citrus and red wine extracts, to determine effects on endothelial function, lipoproteins and inflammation. The primary outcome measure will be endothelial function as assessed by digital response to hyperemia using peripheral arterial tonometry, measured both in the fasting state and after a single standardized high-fat meal, when transient dysfunction is expected to occur. Secondary outcome measures will be the lipid profile, hs-CRP, and Lp-PLA2. The recruitment population will be healthy volunteers. The design will be a randomized, placebo-controlled, double-blind, cross-over trial lasting 10 weeks.
日付
| 最終確認済み: | 02/28/2007 |
| 最初に提出された: | 05/25/2006 |
| 提出された推定登録数: | 05/25/2006 |
| 最初の投稿: | 05/28/2006 |
| 最終更新が送信されました: | 03/13/2007 |
| 最終更新日: | 03/14/2007 |
| 実際の研究開始日: | 04/30/2006 |
| 研究完了予定日: | 11/30/2006 |
状態または病気
介入/治療
Drug: Isotonix OPC-3 (flavonoid supplement)
段階
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | 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.) |
結果
主な結果の測定
1. Change in endothelial function from baseline [undefined]
二次的な結果の測定
1. CRP [undefined]
2. Lipid profile [undefined]
3. Lp-PLA2 [undefined]
