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Study to Evaluate the Effect of a Vegetal Oil on Cognitive Impairment

1 de junio de 2016 actualizado por: Team Foods Colombia S.A.

Randomized, Double Blind, Placebo Controlled Prospective Study, to Evaluate the Effect of a Vegetal Oil in the Disease's Natural Evolution in Patients Diagnosed With Cognitive Impairment or Mild to Moderate Alzheimer Disease.

The aim of the study is to evaluate the beneficial effect of a mixture of vegetal oils with a composition related to short, medium and long unsaturated chain fatty acids on patients with a diagnose of cognitive impairment or mild to moderate Alzheimer disease

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Descripción detallada

The cognitive impairment syndrome is defined as a decrease of the intellectual performance with respect to a previous step in time. The Cognitive impairment has to be considered as a functional alteration with a continuous and physiological evolution in which happen a set of different circumstances:

  • A increasing and normal reduction, that appears after the age of sixty, also known as Age-associated memory impairment (AAMI)
  • A mild cognitive impairment (MCI), with a recent and mild loss of memory, but higher to that expected because of patient's age and educational level.
  • A severe pathological decrease of the mental abilities, also known as, depending on its characteristics: Severe cognitive impairment (SCI), senile dementia and Alzheimer's disease (1).

In the next years it is expected that this disease will become one of the main health and aged-related problem in aged people.(2) Nowadays, there are 35,6 million people with any kind of dementia, and it is estimated that every year, 7,7 million of new patients are diagnosed. (3) The amount of people affected will probably duplicate every 20 years, if effective treatments to stop its evolution are not developed. The forecast estimate up to 81,1 million of patients in 2040, which make this disease in a XXI century real epidemic.(4)

Before reaching the level of dementia, SCI or Alzheimer's disease, the patient will suffer a progressive mild cognitive impairment. In this level, the disease can be early diagnosed and it would be worth to act on it.

Evidences of the Polyunsaturated oils use on the prevention and/or treatment of cognitive impairment.

Polyunsaturated fatty acids (PUFA) can help to improve the cognitive functions. Neuronal tissues, as the brain, retina and the neurone-covering membranes (myelin) include high levels of PUFA. (5) PUFA's act on the order transmission in the Nervous System. Population studies reported the beneficial effect of fish oil, with a high PUFA concentration, on the memory of patients suffering a mild cognitive impairment. (6) It can be also beneficial for Alzheimer's patients, as they are deficient in PUFA's. A diet rich in PUFA'S can improve the cognitive function on patients con cognitive impairment and Alzheimer's disease. (6-8) Epidemiological studies suggest that oils rich in short chain PUFA, should play a beneficial role stopping the initial progression of Alzheimer's disease.

The previous data confirm the possibility of a beneficial effect of the product to study (a mixture of vegetable oils, rich in triglyceride and lecithins) due to the common characteristic of the product with those PUFA's already marketed.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

110

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • España
    • Alicante
      • Elche, Alicante, España, 03293
        • Reclutamiento
        • Hospital Universitario Vinalopó
        • Contacto:
      • Torrevieja,, Alicante, España, 03186

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

55 años a 85 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • informed consents signed by patients and/or caretaker
  • The patient has to fulfil dementia clinical criteria.
  • Age between 55 and 85 years old.
  • MMSE score between 18 and 26.
  • The patient can fulfil all neuropsychologic test, according to investigator.
  • The patient has to be always with his/her caretaker during monitorization visits
  • The caretaker has to be in regular contact with the patient, knowing his/her situation and participation in the study.
  • The caretaker has to check four times per week, at least, the product intake, as well as the routine medication and his/her dietetic habits.
  • Both caretaker and patient have to be able to complete the product intake during all the length of the study, according to the main investigator.

Exclusion Criteria:

  • Patient and/or caretaker not being able to understand and agree in writing their participation in the study.
  • Patient disability to oral intake of products.
  • Known allergy to any of the product components (active and placebo)
  • Evidence of suffering other neuropsychiatric disturbances apart of dementia as: Parkinson disease, psychotic disturbance, bipolar depression.
  • regular intake of alcohol higher than 45 g ethanol/day, during the year before study inclusion.
  • Any known concurrent malignant pathology in the moment of study inclusion, or severe metabolic, cardiovascular, renal, hepatic, or gastrointestinal disease that cannot allow the ending of the study according the investigator.
  • Any analytical abnormality during the screening, apart from: Creatinine no less than 1.7 mg/dL; low levels of Vitamin B12, and TSH abnormal values.

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 paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Lipidic Blend 1
Glass bottle with 45 ml of vegetal mixture oil. 1 bottle per day
Suplemento dietético: Lipidic Blend 1
daily intake of the content of one 45 mL bottle containing the product
Comparador activo: Lipidic Blend 2
Glass bottle with 45 ml of vegetal mixture oil. 1 bottle per day
Suplemento dietético: Lipidic Blend 2
daily intake of the content of one 45 mL bottle containing the product
Comparador de placebos: Placebo
Glass bottle with 45 ml of Olive oil. 1 bottle per day
Suplemento dietético: Placebo
daily intake of the content of one 45 mL bottle containing olive oil

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Changes in Mini-Mental State Examination (MMSE) score
Periodo de tiempo: baseline, 3 month, 6 month, 9 month, 12 month
baseline, 3 month, 6 month, 9 month, 12 month
Changes in Global Clinical Dementia Rating (CDR) score
Periodo de tiempo: baseline, 3 month, 6 month, 9 month, 12 month
baseline, 3 month, 6 month, 9 month, 12 month

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes in systemic oxidative parameters in periferic blood samples (Nitric Oxyde)
Periodo de tiempo: baseline, 12 month
baseline, 12 month
Changes in systemic oxidative parameters in periferic blood samples (Malondialdehyde (MDA))
Periodo de tiempo: baseline, 12 month
baseline, 12 month
Changes in beta-amyloid protein concentration
Periodo de tiempo: baseline, 12 month
Changes in mean values on high sensitivity beta-amyloid 1-40 and 1-42 protein and TAU-protein in cerebrospinal fluid on those patients with a new diagnose of mild to moderate cognitive impairment, that require an initial lumbar puncture and a new lumbar puncture to control evolution at the end of teh study.
baseline, 12 month
Changes in TAU-Protein concentration
Periodo de tiempo: baseline, 12 month
Changes in mean values on high sensitivity beta-amyloid 1-40 and 1-42 protein and TAU-protein in cerebrospinal fluid on those patients with a new diagnose of mild to moderate cognitive impairment, that require an initial lumbar puncture and a new lumbar puncture to control evolution at the end of teh study.
baseline, 12 month
Changes in regular treatment for the cognitive impairment
Periodo de tiempo: baseline, 3 month, 6 month, 9 month, 12 month
baseline, 3 month, 6 month, 9 month, 12 month
Changes in dietetic habits
Periodo de tiempo: baseline, 3 month, 6 month, 9 month, 12 month
baseline, 3 month, 6 month, 9 month, 12 month
Changes in Barthel score
Periodo de tiempo: baseline, 3 month, 6 month, 9 month, 12 month
baseline, 3 month, 6 month, 9 month, 12 month
Changes in Morisky-Green score
Periodo de tiempo: baseline, 3 month, 6 month, 9 month, 12 month
baseline, 3 month, 6 month, 9 month, 12 month
changes in weight
Periodo de tiempo: baseline, 3 month, 6 month, 9 month, 12 month
baseline, 3 month, 6 month, 9 month, 12 month
Number of adverse events
Periodo de tiempo: baseline, 3 month, 6 month, 9 month, 12 month
Number of adverse events related or nonrelated to the study or placebo products.
baseline, 3 month, 6 month, 9 month, 12 month

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Team Foods Colombia S.A.

Colaboradores

Biopolis S.L.

Investigadores

  • Director de estudio: Vicente Navarro-López, MD, Universidad Católica San Antonio de Murcia

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.

Publicaciones Generales

Enlaces Útiles

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 2016

Finalización primaria (Anticipado)

1 de abril de 2017

Finalización del estudio (Anticipado)

1 de julio de 2017

Fechas de registro del estudio

Enviado por primera vez

8 de mayo de 2016

Primero enviado que cumplió con los criterios de control de calidad

17 de mayo de 2016

Publicado por primera vez (Estimar)

20 de mayo de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

3 de junio de 2016

Última actualización enviada que cumplió con los criterios de control de calidad

1 de junio de 2016

Última verificación

1 de mayo de 2016

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • ALZ-OIL.01

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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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