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- Ensayo clínico NCT02647333
Intervention With Omega Fatty Acids in High-risk Patients
19 de diciembre de 2016 actualizado por: Haukeland University Hospital
Intervention With Omega Fatty Acids in High-risk Patients With Hypertriglyceridemic Waist
In order to reduce cardiovascular risk, current European guidelines recommend a diet low on saturated fatty acid through replacement with polyunsaturated fatty acids (PUFA).
Polyunsaturated fatty acids can be classified into omega-3 and omega-6.
However the results from recent meta-analyses investigating coronary risk outcomes did not clearly support a low intake of saturated fatty acids and a high intake of omega-3 or omega-6.
The aim of this study is to investigate the short term effects of a high intake of PUFAs on microvascular function, lipids, inflammation and other cardiovascular risk factors in inactive patients with increased waistline.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
40
Fase
- Fase 2
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
30 años a 70 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Waist circumference ≥ 94 cm in men and ≥ 80 cm in women
- Physical inactivity (< 2 h vigorous/active exercise training per week)
Exclusion Criteria:
- Regular use of certain prescription medications at baseline
- Severe psychiatric illness
- Pregnancy
- Pacemaker or implantable cardioverter defibrillator
- Cigarette smoking
- Previous coronary intervention
- Concomitant use of dietary supplements
- Use of omega-3 supplements at baseline
- Alcohol or drug abuse or any condition associated with poor compliance.
- Scheduled hospitalisation during the course of the study.
- Participation in a clinical trial in the last 12 weeks, or prior randomisation.
- Blood donation within the preceding 12 weeks.
- Diabetes Mellitus Type 1 or type 2
- Triglycerides > 5 mmol/l
- Previous bariatric surgery
- Malabsorption disorder
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Omega-3 fatty acid
Omega-3 fatty acids for 8 weeks, dosage are 3 and 4 g/day for women and men, respectively.
|
Experimental: Omega-3 fatty acid In the intervention period the participants will receive a daily supplement of omega-3 fatty acids for 8 weeks, where the dosage are 3 and 4 g/day for women and men, respectively.
The omega-3 supplement is a hydrolyzed and reesterified TAG fish oil, containing 33 area percent eicosapentaenoic acid and 22 area percent docosahexaenoic acid.
Otros nombres:
|
Experimental: Omega-6 fatty acid
Omega-6 fatty acids for 8 weeks, dosage are 20 and 27 g/day for women and men, respectively.
|
Experimental: Omega-6 fatty acid In the intervention period the participants will receive a daily supplement of omega-6 fatty acid for 8 weeks, where the dosage are 20 and 27 g/day for women and men, respectively.
The omega-6 supplement is a high-quality organic, cold pressed and filtered safflower oil, containing 68-83% linoleic acid, 5-15% saturated fatty acid, 8-21% oleic acid, 0,0-0,5% ALA and maximum 2% other fatty acids.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Changes in lipid profile
Periodo de tiempo: Measured at baseline and after 8 weeks
|
High-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), total cholesterol and triglycerides (TG) will be measured in plasma/serum (mmol/L).
|
Measured at baseline and after 8 weeks
|
Changes in particle concentrations of lipoproteins of different sizes
Periodo de tiempo: Measured at baseline and week 8
|
Particle concentration (nmol/L) of lipoprotein of different sizes will be calculated from the measured amplitude of their spectroscopically lipid methyl group NMR signals.
|
Measured at baseline and week 8
|
Changes in lipoprotein particle sizes
Periodo de tiempo: Measured at baseline and week 8
|
Lipoprotein particle size (nm) analysis will be performed by proton nuclear magnetic resonance (NMR) spectroscopy.
The size will be derived from the sum of diameter of each subclass multiplied by its relative mass percentage based on its methyl NMR signal.
|
Measured at baseline and week 8
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Changes in body composition
Periodo de tiempo: Measured at baseline and week 8
|
Body composition will be measured by bioelectrical impedance (InBody 720).
|
Measured at baseline and week 8
|
Changes in body weight
Periodo de tiempo: Measured at baseline and week 8
|
Measured at baseline and week 8
|
|
Changes in waist and hip circumference
Periodo de tiempo: Measured at baseline and week 8
|
Measured at baseline and week 8
|
|
Changes in circulating markers of inflammation, also including adipokines and kynurenine
Periodo de tiempo: Measured at baseline and week 8
|
Inflammatory markers and adipokines will be measured in serum/plasma, e.g tumor necrosis factor-α (TNF-α), interleukins, macrophage inflammatory protein 1-α (MIP-1-α) and granulocyte-macrophage colony stimulating factor (GM-CSF).
|
Measured at baseline and week 8
|
Changes in markers of inflammation in adipose tissue
Periodo de tiempo: Measured at baseline and week 8
|
Inflammatory markers like TNF-α, interleukins, GM-CSF and adiponectin in will be measured in adipose tissue (pg/mg tissue).
|
Measured at baseline and week 8
|
Changes in one carbon metabolites
Periodo de tiempo: Measured at baseline and week 8
|
Choline, betaine and related metabolites and B-vitamins involved in 1-carbon metabolism.
|
Measured at baseline and week 8
|
Changes in microbiota
Periodo de tiempo: Measured at baseline and week 8
|
Bacterial DNA in stool samples will be subjected to high-throughput barcode multiplex sequencing of the 16s ribosomal RNA gene (rRNA).
|
Measured at baseline and week 8
|
Changes in endothelial function
Periodo de tiempo: Measured at baseline and week 8
|
Vascular reactivity index (VRI) will be measured by monitoring fingertip temperature changes during a reactive hyperemia protocol.
|
Measured at baseline and week 8
|
Changes in carnitine and metabolites
Periodo de tiempo: Measured at baseline and week 8
|
Trimethylamine N-oxide (TMAO), carnitine, acylcarnitines and fatty acids will be measured in serum/plasma.
|
Measured at baseline and week 8
|
Changes in gene expression in adipose tissue
Periodo de tiempo: Measured at baseline and week 8
|
Gene expression in adipose tissue will be measured by microarray and quantitative PCR.
|
Measured at baseline and week 8
|
Changes in amino acids
Periodo de tiempo: Measured at baseline and week 8
|
Amino acids, methylated amino acids and metabolites will be measured in serum/plasma.
|
Measured at baseline and week 8
|
Changes in gene expression i whole blood
Periodo de tiempo: Measured at baseline and week 8
|
Gene expression in full blood will be measured by quantitative PCR.
|
Measured at baseline and week 8
|
Changes in apolipoproteins
Periodo de tiempo: Measured at baseline and week 8
|
Apolipoproteins A1, A2, B, C2, C3 and E will be measured in serum by a multiplex kit.
|
Measured at baseline and week 8
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Espen Rostrup, MD PhD, Haukeland University Hospital, Department of Heart Disease
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de marzo de 2015
Finalización primaria (Actual)
1 de abril de 2016
Finalización del estudio (Actual)
1 de abril de 2016
Fechas de registro del estudio
Enviado por primera vez
9 de septiembre de 2015
Primero enviado que cumplió con los criterios de control de calidad
4 de enero de 2016
Publicado por primera vez (Estimar)
6 de enero de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
20 de diciembre de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
19 de diciembre de 2016
Última verificación
1 de diciembre de 2016
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2014/2336
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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