The Effect of Strawberries in a Cholesterol-Lowering Dietary Portfolio
The Long-Term Effect of Viscous Fibers, Soy Protein, and Plant Sterol Foods in Combination on Serum Cholesterol and Other Risk Factors for Cardiovascular Disease
調査の概要
詳細な説明
We have shown in 1-month metabolic studies that the dietary portfolio can lower cholesterol to the same extent as first generation statins (cholesterol-lowering drugs). In the on-going long-term 'real world' study using this dietary portfolio, only one-third of participants were able to achieve similar cholesterol reductions at the end of 1 year. Varying compliance has been identified as the main issue why the other two-thirds could not achieve a similar level of reduction. We believe the addition of strawberries to this diet, by virtue of their beneficial components (fibre and antioxidants)and by replacement of less desirable foods (fatty deserts), may further improve the CHD risk profile of a very effective cholesterol reduction strategy.
Method:
454 g of strawberries per 2000 kcal per day will be provided for a one-month period to approximately 40-50 subjects on a long-term dietary portfolio study, all of whom have been on the diet for at least 6 months to 1 year. The active dietary components consist of viscous vibers (including oat bran), soy products (including soy milk), almonds and plant sterols (sterol enriched margarine). Strawberry recipes will be used to enhance compliance of these components. Subjects will undergo the study in a randomized crossover design where the control will be the dietary portfolio with additional 65 g oatbran bread (without psyllium) replacing the strawberries.
Bloods will be taken at weeks 0, 2 and 4 of each treatment period; and at one month prior to and after the 8-week study while on the long-term dietary portfolio.
研究の種類
入学
段階
- フェーズ2
連絡先と場所
研究場所
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Ontario
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Toronto、Ontario、カナダ、M5C 2T2
- Clinical Nutrition & Risk Factor Modification Centre, St. Michael's Hospital Health Centre
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Healthy adult men and postmenopausal women currently enrolled in the long-term dietary portfolio study
- Body mass index <32 kg/m2
- constant body weight over last 6 months preceding the onset of the study
- Fasting LDL cholesterol concentration>4.1 mmol/L at diagnosis
Exclusion Criteria:
- women of child-bearing potential
- major cardiovascular event (stroke or myocardial infarction)
- positive molecular diagnosis of familial hypercholesterolemia
- secondary causes of hypercholesterolemia (hypothyroidism, unless treated & on a stable dose of L-thyroxine, renal or liver disease)
- use of cholesterol-lowering medications
- serum triglycerides >4.5 mmmol/L
- blood pressure > 145/90 mmHg
- diabetes and or major disorders such as liver disease, renal failure or cancer
- major surgery <6 months prior to randomization
- alcohol consumption > 2 drinks per day
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
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Total cholesterol measured at weeks 0, 2, and 4 of each phase
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LDL cholesterol measured at weeks 0, 2, and 4 of each phase
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C-reactive protein measured at weeks 0, 2 and 4 of each phase
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Blood pressure measured at weeks 0, 2 and 4 of each phase
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二次結果の測定
結果測定 |
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Apolipoprotein A1 and B measured at weeks 0, 2, and 4 of each phase
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Lp(a) measured at weeks 0, 2, and 4 of each phase
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Oxidative stress measured at weeks 0, 2, and 4 of each phase
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Strawberry intake measured at weeks 0, 2, and 4 of each phase
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Compliance to portfolio diet components measured at weeks 0, 2 and 4 of each phase
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24 hour urinary potassium measured at weeks 0 and 4 of each phase
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24 hour urinary calcium measured at weeks 0 and 4 of each phase
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協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：David JA Jenkins, MD PhD DSc、Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, 150 College St. Rm 340, Toronto, ON M5S 3E2, Canada
研究記録日
主要日程の研究
研究開始
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- REB 03-043C
- HC-CT#100934
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