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Набор скоро начнётся NCT07690384

Effects of Functional Oils on Obesity With Mild Cognitive Impairment

Без фазы С лечением Obesity Mild Cognitive Impairment

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Rapeseed Oil (RSO), Diacylglycerol Oil (DAG Oil).
Кому может быть актуально
Состояния в реестре: Obesity, Mild Cognitive Impairment. Базовые параметры: 45 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

Interventional Study of Functional Oils Improving Obesity With Mild Cognitive Impairment Via Regulating White Adipose Tissue Browning

Обзор

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.

Подробное описание

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.

Вмешательства

  • Пищевая добавка Rapeseed Oil (RSO)
    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.
  • Пищевая добавка Diacylglycerol Oil (DAG Oil)
    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.

Первичные конечные точки

  • Change From Baseline in Cognitive Function [Срок оценки: Baseline and 6 months]
  • Change From Baseline in Body Weight [Срок оценки: Baseline and 6 months]
  • Change From Baseline in Body Fat Percentage [Срок оценки: Baseline and 6 months]
Вторичные конечные точки (3)
  • Change From Baseline in Visceral Fat Area [Срок оценки: Baseline and 6 months]
  • Change From Baseline in Serum Lipid Concentrations [Срок оценки: Baseline and 6 months]
  • Change in Gut Microbiota Composition and Metabolites [Срок оценки: Baseline and 6 months]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Capital Medical University — Пекин

Идентификаторы

NCT: NCT07690384 · CNS-NNSRG2024-139

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗