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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00886704
Omega-3 Fatty Acids, the Omega-3 Index, and Atherosclerosis
Influence of Dietary Omega-3 Fatty Acids in a Convenience Drink (Smartfish) on the Omega-3 Index in Patients With Atherosclerotic Disease
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Munich, Alemania, 80336
- Preventive Cardiology
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Subjects must meet the current guideline criteria for atherosclerosis, like coronary, peripheral or carotid artery disease, like previous myocardial infarction or acute coronary syndrome, coronary revascularization (operation or transluminally), or positive angiography or ultrasound.
- Age: 30 - 75 years
- Low Omega-3 Index (<5%)
- Subjects must have adequate fluency in German or English to complete baseline and follow-up interviews.
- Stable intake of food containing EPA+DHA before and during study
- Subjects must be able and willing to give written informed consent, and to comply with study procedures.
Exclusion Criteria:
- Subjects for whom the intake of omega-3 fatty acids is mandatory according to recent treatment guidelines or who take omega-3 fatty acids supplements on a regular basis.
- Patients consuming >2 portions of fatty fish / week
- Patients with serious bleeding disorder. Use of platelet inhibitors or anticoagulation with a target INR of 2.0 - 3.0 is not an exclusion criterion.
- Subjects with any acute and life-threatening condition, such as collapse and shock, acute myocardial infarction (last three months), stroke, embolism.
- Subjects with significant medical co-morbidity, seriously limiting life expectancy or insulin-treated diabetes mellitis or a BMI>30
- Allergy/intolerance or history of hypersensitivity to components of study intervention, like lactose.
- Pregnant subjects - due to any possible teratogenic effects of study nutrition on the fetus - and breastfeeding subjects. In addition, women of childbearing potential who will not practice a medically accepted method of contraception will be excluded.
- Subjects who, in the investigator's judgement, will not likely be able to comply with the study protocol or with known drug- or alcohol abuse/dependence in the past 2 years.
- Use of any investigational agents within 30 days prior to t0
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Convenience drink with EPA and DHA
Daily consumption of 200 ml convenience drink, containing 0.5 g EPA and DHA (Omega-3 Fatty Acids)
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Composition of active convenience drink (smartfish): 200 ml drink, enriched with 940 mg omega-3 fatty acids, of which 200 mg are EPA, 300 mg DHA and 100 mg DPA, slightly carbonized.. Energy content 486 kJ (116 kcal), protein 0.6 g, Carbohydrates 22 g, total fat 4 g, of which 0.6 g saturated fatty acids, 1.8 g monounsaturates, 1.4 g polyunsaturates. Vitamin D 0.85 ug. Control convenience drink: as above, containing about 1 g Omega-6 fatty acids from e.g. corn oil. |
Comparador de placebos: Convenience drink without EPA and DHA
Daily consumption of 200 ml convenience drink, not containing 0.5 g EPA and DHA (Omega-3 Fatty Acids), but containing 1.0 g of Omega-6 Fatty Acids (e.g. corn oil)
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Composition of active convenience drink (smartfish): 200 ml drink, enriched with 940 mg omega-3 fatty acids, of which 200 mg are EPA, 300 mg DHA and 100 mg DPA, slightly carbonized.. Energy content 486 kJ (116 kcal), protein 0.6 g, Carbohydrates 22 g, total fat 4 g, of which 0.6 g saturated fatty acids, 1.8 g monounsaturates, 1.4 g polyunsaturates. Vitamin D 0.85 ug. Control convenience drink: as above, containing about 1 g Omega-6 fatty acids from e.g. corn oil.
Control convenience drink: as above, containing about 1 g Omega-6 fatty acids from e.g. corn oil.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Omega-3 Index
Periodo de tiempo: after eight weeks of intervention
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Percentage of eicosapentaenoic and docosahexaenoic acids in total red cell fatty acids, as determined with a standardized analytical procedure, i.e. the HS-Omega-3 Index.
Currently, the target range for the HS-Omega-3 Index has been suggested to be between 8% and 11%.
Cardiovascular risk increases at levels below 8%, whereas levels above 11% do not seem to confer further benefit.
Values of the HS-Omega-3 Index have been found between 1.5% and 20%.
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after eight weeks of intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Palatability
Periodo de tiempo: at 8 weeks
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Palatability assessed as number on a visual analogue scale from 0 - 10, with 0 being the worst and 10 being the best possible outcome
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at 8 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Clemens von Schacky, MD, Ludwig-Maximilians - University of Munich
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 477-08
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Ensayos clínicos sobre 500 mg eicosapentaenoic (EPA) plus docosahexaenoic acids (DHA)
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University of MichiganTerminado