Mild Cognitive Impairment, Obesity
Conditions
Keywords
Functional Oil, Dietary Intervention
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTRapeseed 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.
DIETARY_SUPPLEMENTDiacylglycerol 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.
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Cognitive Function | Baseline and 6 months | 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. |
| Change From Baseline in Body Weight | Baseline and 6 months | Change from baseline in body weight (kg) measured by bioelectrical impedance analysis (InBody body composition analyzer). |
| Change From Baseline in Body Fat Percentage | Baseline and 6 months | Change from baseline in body fat percentage measured by bioelectrical impedance analysis (InBody body composition analyzer). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Visceral Fat Area | Baseline and 6 months | Change from baseline in visceral fat area measured by bioelectrical impedance analysis (InBody body composition analyzer). |
| Change From Baseline in Serum Lipid Concentrations | Baseline and 6 months | 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. |
| Change in Gut Microbiota Composition and Metabolites | Baseline and 6 months | 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. |
Countries
China
Contacts
CONTACTJiaxuan Tao
PRINCIPAL_INVESTIGATORRong Xiao, PhD
Capital Medical University
Outcome results
None listed