Effects of Functional Oils on Obesity With Mild Cognitive Impairment
5 de julio de 2026 actualizado por: Jiaxuan Tao, Capital Medical University
Interventional Study of Functional Oils Improving Obesity With Mild Cognitive Impairment Via Regulating White Adipose Tissue Browning
The purpose of this study is to investigate the effects of diacylglycerol (DAG) oil on obesity accompanied by mild cognitive impairment (MCI).
Participants aged 45 to 75 years with obesity and MCI will be randomly assigned to two groups: a control group receiving regular rapeseed oil (RSO) and an experimental group receiving rapeseed-based DAG oil.
The dietary intervention will last for 6 months.
The main goal is to observe whether this functional oil intervention can improve cognitive function and regulate white adipose tissue browning.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
Obesity is a significant risk factor for the development of cognitive impairment, making precise nutritional interventions a vital strategy for preventing and managing this condition. Based on an established cohort, this randomized controlled trial aims to evaluate the efficacy of substituting regular dietary oil with functional diacylglycerol (DAG) oil in obese patients with MCI.
The study will analyze changes in overall cognitive function, body composition, and dietary quality before and after the 6-month intervention. Furthermore, the study will explore the underlying mechanisms by analyzing biological samples (blood and feces) for alterations in lipid metabolites, gut microbiota composition, inflammatory cytokines, and specific markers of white adipose tissue browning. The findings will help determine the therapeutic potential of DAG oil in regulating lipid metabolism and delaying cognitive decline.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
100
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.
Estudio Contacto
- Nombre: Jiaxuan Tao
- Número de teléfono: +86-15389510275
- Correo electrónico: taojxxx@163.com
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100069
- Capital Medical University
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Contacto:
- Rong Xiao, PhD
- Número de teléfono: +86-18611314617
- Correo electrónico: xiaor22@ccmu.edu.cn
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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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Meets the diagnostic criteria for obesity combined with mild cognitive impairment (MCI) (obesity: BMI ≥28.0 kg/m^2 per the 2022 Chinese Expert Consensus on Obesity Prevention and Treatment; MCI: Montreal Cognitive Assessment [MoCA] score below the education-adjusted cutoff, confirmed by a neurologist)
- Aged 45 to 75 years
- Has not been on a diet or has discontinued dieting for at least 3 months, and has not taken fish oil or similar supplements, or is willing to discontinue such supplements for 3 months prior to the intervention
- Able to accept and consume DAG oil as part of daily diet
- Voluntarily agrees to participate and signs the informed consent form
Exclusion Criteria:
- History of neuropsychiatric disorders such as stroke, epilepsy, or schizophrenia
- Cognitive impairment attributable to depression, thyroid disease, traumatic brain injury, or drug- or alcohol-induced intoxication
- History of cerebrovascular disease, or cognitive decline due to severe impairment of cardiac, hepatic, pulmonary, or renal function
- Use of antibiotics, health products, or nutritional supplements within 2 weeks prior to fecal sample collection; or gastrointestinal symptoms (trauma, inflammation/infection, abdominal pain, diarrhea, or constipation) or vaccination history within the same period
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: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador de placebos: RSO Group (Rapeseed Oil)
Participants with obesity and mild cognitive impairment (MCI) will be provided with conventional rapeseed oil (RSO), in which diacylglycerol (DAG) occurs only at the low level naturally present in regular cooking oil (predominantly triacylglycerol), for household use for 6 months.
Dietary guidance based on balanced nutrition principles will be provided.
Compliance, dietary intake, anthropometric, biochemical, and cognitive assessments will be evaluated at baseline and 6 months.
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A commercially available conventional rapeseed oil for daily household cooking use, containing diacylglycerol (DAG) only at the trace level naturally occurring in regular vegetable oil.
Otros nombres:
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Experimental: DAG Group (Diacylglycerol Oil)
Participants with obesity and MCI will be provided with rapeseed oil-based diacylglycerol (DAG) oil (DAG content ≥40%), produced from conventional rapeseed oil via lipase-catalyzed enzymatic conversion followed by distillation, deodorization, and decolorization, for household use for 6 months, replacing conventional cooking oil.
Dietary guidance based on balanced nutrition principles will be provided.
Compliance, dietary intake, anthropometric, biochemical, and cognitive assessments will be evaluated at baseline and 6 months.
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A rapeseed oil-based functional oil produced via lipase-catalyzed enzymatic conversion, with a diacylglycerol content ≥40% (national standard requirement), for daily household cooking use in place of conventional cooking oil.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change From Baseline in Cognitive Function
Periodo de tiempo: Baseline and 6 months
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Change from baseline in cognitive function assessed by the Montreal Cognitive Assessment (MoCA), which evaluates visuospatial/executive function, naming, memory, attention, language, abstraction, delayed recall, and orientation.
Total score ranges from 0 to 30, with higher scores indicating better cognitive function.
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Baseline and 6 months
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Change From Baseline in Body Weight
Periodo de tiempo: Baseline and 6 months
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Change from baseline in body weight (kg) measured by bioelectrical impedance analysis (InBody body composition analyzer).
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Baseline and 6 months
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Change From Baseline in Body Fat Percentage
Periodo de tiempo: Baseline and 6 months
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Change from baseline in body fat percentage measured by bioelectrical impedance analysis (InBody body composition analyzer).
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Baseline and 6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline in Visceral Fat Area
Periodo de tiempo: Baseline and 6 months
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Change from baseline in visceral fat area measured by bioelectrical impedance analysis (InBody body composition analyzer).
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Baseline and 6 months
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Change From Baseline in Serum Lipid Concentrations
Periodo de tiempo: Baseline and 6 months
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Change from baseline in serum total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C), measured by automated biochemical analyzer.
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Baseline and 6 months
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Change in Gut Microbiota Composition and Metabolites
Periodo de tiempo: Baseline and 6 months
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Change from baseline in fecal gut microbiota composition, alpha/beta diversity, and microbial abundance assessed by 16S ribosomal RNA sequencing, and in microbial metabolites including short-chain fatty acids (e.g., butyrate) assessed by untargeted metabolomics.
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Baseline and 6 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Rong Xiao, PhD, Capital Medical 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 (Estimado)
1 de julio de 2026
Finalización primaria (Estimado)
1 de enero de 2027
Finalización del estudio (Estimado)
1 de marzo de 2027
Fechas de registro del estudio
Enviado por primera vez
29 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
5 de julio de 2026
Publicado por primera vez (Actual)
8 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
5 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Desordenes mentales
- Trastornos Nutricionales
- Sobrenutrición
- Peso corporal
- Trastornos neurocognitivos
- Trastornos cognitivos
- Exceso de peso
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Obesidad
- Disfunción congnitiva
- Lípidos
- Preparaciones de plantas
- Productos biológicos
- Mezclas complejas
- Aceites vegetales
- Aceites
- Glicéridos
- Aceite de colza
- Diglicéridos
Otros números de identificación del estudio
- CNS-NNSRG2024-139
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
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