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
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Ontario
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Toronto, Ontario, Canadá, M5C 2T2
- Clinical Nutrition & Risk Factor Modification Centre, St. Michael's Hospital Health Centre
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
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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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Medidas de resultados secundários
Medida de resultado |
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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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- REB 03-043C
- HC-CT#100934
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