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Feasibility and Efficacy of Dietary Interventions for Older Adults With Subjective Cognitive Decline

1 de octubre de 2019 actualizado por: Johns Hopkins University

This study aims to assess if/how dietary interventions (i.e., the Modified Atkins Diet (MAD) and/or the Mediterranean-Dietary Approaches to Stop Hypertension (DASH) Intervention for Neurodegenerative Delay (MIND)) might prevent, delay onset, alleviate symptoms, or otherwise alter the course of subjective cognitive decline (SCD) likely due to Alzheimer's disease (AD).

We hypothesize that participants will tolerate both diets well and that the MAD will result in more favorable changes in cognition and other functioning.

Descripción general del estudio

Estado

Retirado

Condiciones

Intervención / Tratamiento

Descripción detallada

Specific aims are to 1) to establish the feasibility of implementing the MAD in older adults with subjective cognitive decline (SCD) likely due to AD, 2) to examine whether changes in participants' cognition, mood, or other functioning are more favorable in patients using the MAD than in patients using the MIND diet, 3) to assess the role of Apolipoprotein E (ApoE) epsilon 4 genotype in response to the MAD in individuals with SCD. We hypothesize that 1) participants will be able to adhere to and tolerate the MAD and the MIND, determined by review of patients' food records and urine ketone production, 2) participants who adhere to the MAD will demonstrate a more favorable change on neuropsychological tests than participants on the MIND diet, and 4) the neuropsychological effects of the MAD will be greatest in those participants without a ε4 allele of the ApoE gene.

Tipo de estudio

Intervencionista

Fase

  • No aplica

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

60 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Self-experienced persistent decline in cognitive capacity compared with a previously normal status that is unrelated to an acute event and that is not explained by a psychiatric disorder or neurological disease apart from Alzheimer's disease, medical disorder, medication, or substance use, with the onset of decline no longer than 5 years prior to study participation
  • Clinical Dementia Rating (CDR) score equal to 0
  • Montreal Cognitive Assessment (MoCA) equal to or greater than 26
  • Age 60 years or older
  • Personal physician clearance
  • Willing to comply with all requirements of the study protocol and provide informed consent

Exclusion Criteria:

  • Diagnosis of mild cognitive impairment (MCI), Alzheimer's disease (AD), or other dementia
  • Current psychiatric diagnosis
  • Unstable metabolic condition (documented on screening laboratory studies performed within the past year)
  • persistent hyponatremia (sodium < 130 mg/dL twice within the past year)
  • severe hypernatremia (sodium > 150 mg/dL twice within the past year)
  • hypoglycemia (glucose < 50 mg/dL)
  • hypocalcemia (albumin-corrected calcium < 8 mg/dL)
  • Type-I diabetes
  • Type-2 diabetes requiring any medication other than metformin. (Please note that patients with type-2 diabetes may require medication adjustment if on the very low-carb modified Atkins diet.)
  • Liver failure
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or ammonia > 5x upper limits of normal
  • hyperbilirubinemia
  • total bilirubin > 15 mg/dL
  • direct bilirubin > 5 mg/dL
  • Hypercholesterolemia (on medication, if needed)
  • fasting total cholesterol > 300 mg/dL
  • fasting LDL cholesterol > 200 mg/dL
  • Known fatty acid oxidation disorder or pyruvate carboxylase deficiency
  • Body mass index < 18.5
  • History of ischemic or hemorrhagic stroke
  • History of nephrolithiasis
  • History of myocardial infarction or known coronary artery disease
  • Acute pancreatitis
  • Multiple food allergies or strict dietary requirements
  • Any other concerns about nutritional status (e.g., recent unexplained weight loss, difficulty swallowing)

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: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Modified Atkins Diet (MAD)
A diet that can produce ketones
Suplemento dietético: MAD
A high fat, low carbohydrate diet
Comparador activo: MIND diet
Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND). A diet that has been indicated to be helpful in preventing or decreasing cognitive decline.
Suplemento dietético: MIND
A combination of the Mediterranean and DASH diets

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Memory Functioning Questionnaire (MFQ)
Periodo de tiempo: Baseline/week-0, week-6, completion/week-12
This is a self-report assessment of cognitive decline. It is rated on a 1-7 scale, with 1 indicating "major problems" and 7 indicating "no problems." It includes 8 sections, each including 1-18 sub-questions. It will be assessed by comparing changes in scores between groups and across time (12 weeks).
Baseline/week-0, week-6, completion/week-12
Change in Loewenstein-Acevedo Scales of Semantic Interference and Learning (LASSI-L)
Periodo de tiempo: Baseline/week-0, week-6, completion/week-12
This is an assessment of verbal learning and memory for lists of 15 words. More words learned and remembered indicate better learning and memory. It will be assessed by comparing changes in scores between groups and across time (12 weeks).
Baseline/week-0, week-6, completion/week-12
Change in Para-Rodriguez Short-term Visual Memory Binding Test (SVMBT)
Periodo de tiempo: Baseline/week-0, week-6, completion/week-12
This is an assessment of visual recognition memory for shapes and colors. More accurate recognition indicates better recognition memory. It will be assessed by comparing changes in scores between groups and across time (12 weeks).
Baseline/week-0, week-6, completion/week-12
Change in Ketone levels
Periodo de tiempo: Checked by the participant daily, for 12 weeks/3 months (i.e., from the start day of the diet until the end of the 12 weeks) and checked by the study staff at each study visit (i.e., baseline/week-0, week-3, week-6, and completion/week-12)
This is detected in urine and measured in mg/dL, with higher levels indicating greater production of ketones and greater adherence to the MAD diet. Adherence will be assessed by percent of participants in the MAD group in at least moderate ketosis (>40 mg/dl) at 3 or more follow-up visits.
Checked by the participant daily, for 12 weeks/3 months (i.e., from the start day of the diet until the end of the 12 weeks) and checked by the study staff at each study visit (i.e., baseline/week-0, week-3, week-6, and completion/week-12)
MIND Diet Score
Periodo de tiempo: 12 weeks/3 months (i.e., from the start day of the diet until the end of the 12 weeks)
This is assessed by dietitian review of participants daily food logs. Scores range from 0 (not at all adherent) to 15 (perfectly adherent). Any score greater than 9 is considered adherent. It will be assessed by percent of participants in the MIND group with scores of at least 9 at 3 or more follow-up visits.
12 weeks/3 months (i.e., from the start day of the diet until the end of the 12 weeks)
ApoE epsilon 4 status
Periodo de tiempo: Tested via venipuncture or buccal swab at baseline/week-0
This is a genetic marker of Alzheimer's disease risk. It will be coded as positive (one or more epsilon 4 alleles) or negative (no epsilon 4 alleles). It will be evaluated by stratifying the sample by the presence of at least one ε4 allele and conditioning the efficacy analyses by this variable.
Tested via venipuncture or buccal swab at baseline/week-0

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Trail Making Test
Periodo de tiempo: Baseline, week-6, week-12
This is a timed test of processing speed and executive functioning. Faster time to completion and fewer errors indicate better processing speed and executive functioning. It will be assessed by comparing changes in scores between groups and across time (12 weeks).
Baseline, week-6, week-12
Change in Prospective Memory Test
Periodo de tiempo: Baseline, week-6, week-12
This is a test of remembering to ask that a borrowed item be returned. The possible scores range from 0 (no cues needed to remember to ask) to 4 (4 cues needed to remember to ask). More cues required indicates worse prospective memory. It will be assessed by comparing changes in scores between groups and across time (12 weeks).
Baseline, week-6, week-12
Change in Geriatric Anxiety Scale
Periodo de tiempo: Baseline, week-6, week-12
This is a self-report measure of symptoms of anxiety in older persons. It is rated on a 0 (not at all) to 3 (all of the time) scale. Scores range from 0-90, with higher scores indicating more anxiety. It will be assessed by comparing changes in scores between groups and across time (12 weeks).
Baseline, week-6, week-12
Change in Geriatric Depression Scale
Periodo de tiempo: Baseline, week-6, week-12
This is a self-report measure of symptoms of depression in older persons. Items are rated as yes/no. Scores range from 0-30, with higher scores indicating more depression. It will be assessed by comparing changes in scores between groups and across time (12 weeks).
Baseline, week-6, week-12

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Cognitive decline concern questionnaire
Periodo de tiempo: Baseline, week-6, week-12
This is a one question questionnaire that asks how concerned/worried a person is about their subjective cognitive decline on a 1 (majorly worried) to 7 (not at all worried) scale, with higher scores indicating a greater degree of concern/worry. It will be assessed by comparing changes in scores between groups and across time (12 weeks).
Baseline, week-6, week-12

Colaboradores e Investigadores

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

Patrocinador

Johns Hopkins University

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 (Anticipado)

2 de septiembre de 2019

Finalización primaria (Anticipado)

1 de septiembre de 2021

Finalización del estudio (Anticipado)

1 de septiembre de 2021

Fechas de registro del estudio

Enviado por primera vez

21 de junio de 2018

Primero enviado que cumplió con los criterios de control de calidad

2 de julio de 2018

Publicado por primera vez (Actual)

13 de julio de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de octubre de 2019

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

1 de octubre de 2019

Última verificación

1 de octubre de 2019

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • IRB00175761

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

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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