Effects of Functional Oils on Obesity With Mild Cognitive Impairment
2026年7月5日 更新者：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.
調査の概要
状態
まだ募集していません
詳細な説明
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.
研究の種類
介入
入学 (推定)
100
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Jiaxuan Tao
- 電話番号：+86-15389510275
- メール：taojxxx@163.com
研究場所
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Beijing Municipality
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Beijing、Beijing Municipality、中国、100069
- Capital Medical University
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コンタクト：
- Rong Xiao, PhD
- 電話番号：+86-18611314617
- メール：xiaor22@ccmu.edu.cn
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター：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.
他の名前：
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実験的：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline in Cognitive Function
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline in Visceral Fat Area
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Rong Xiao, PhD、Capital Medical University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月1日
一次修了 (推定)
2027年1月1日
研究の完了 (推定)
2027年3月1日
試験登録日
最初に提出
2026年6月29日
QC基準を満たした最初の提出物
2026年7月5日
最初の投稿 (実際)
2026年7月8日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月8日
QC基準を満たした最後の更新が送信されました
2026年7月5日
最終確認日
2026年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。