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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RSO Group (Rapeseed Oil) | Placebo Comparator | 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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| DAG Group (Diacylglycerol Oil) | Experimental | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapeseed Oil (RSO) | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Cognitive Function | 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. | Baseline and 6 months |
| Change From Baseline in Body Weight | Change from baseline in body weight (kg) measured by bioelectrical impedance analysis (InBody body composition analyzer). | Baseline and 6 months |
| Change From Baseline in Body Fat Percentage | Change from baseline in body fat percentage measured by bioelectrical impedance analysis (InBody body composition analyzer). | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Visceral Fat Area | Change from baseline in visceral fat area measured by bioelectrical impedance analysis (InBody body composition analyzer). | Baseline and 6 months |
| Change From Baseline in Serum Lipid Concentrations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiaxuan Tao | Contact | +86-15389510275 | taojxxx@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Rong Xiao, PhD | Capital Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capital Medical University | Beijing | Beijing Municipality | 100069 | China |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000074262 | Rapeseed Oil |
| D004075 | Diglycerides |
| ID | Term |
|---|---|
| D010938 | Plant Oils |
| D009821 | Oils |
| D008055 | Lipids |
| D028321 | Plant Preparations |
| D001688 |
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|
| Diacylglycerol Oil (DAG Oil) | Dietary Supplement | 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. |
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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.
| Baseline and 6 months |
| Change in Gut Microbiota Composition and Metabolites | 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. | Baseline and 6 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| Biological Products |
| D045424 | Complex Mixtures |
| D005989 | Glycerides |