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
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Ontario
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Toronto, Ontario, Canada, M5C 2T2
- Clinical Nutrition & Risk Factor Modification Centre, St. Michael's Hospital Health Centre
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
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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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Secundaire uitkomstmaten
Uitkomstmaat |
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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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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: 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
Studie record data
Bestudeer belangrijke data
Studie start
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
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Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- REB 03-043C
- HC-CT#100934
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