Effects of Functional Oils on Obesity With Mild Cognitive Impairment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rapeseed Oil (RSO), Diacylglycerol Oil (DAG Oil).
- Who it may be relevant to
- Registry conditions: Obesity, Mild Cognitive Impairment. Basic parameters: 45 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Interventional Study of Functional Oils Improving Obesity With Mild Cognitive Impairment Via Regulating White Adipose Tissue Browning
Overview
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 supplement 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. - Dietary supplement 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.
Primary outcome measures
- Change From Baseline in Cognitive Function [Time frame: Baseline and 6 months]
- Change From Baseline in Body Weight [Time frame: Baseline and 6 months]
- Change From Baseline in Body Fat Percentage [Time frame: Baseline and 6 months]
Secondary outcome measures (3)
- Change From Baseline in Visceral Fat Area [Time frame: Baseline and 6 months]
- Change From Baseline in Serum Lipid Concentrations [Time frame: Baseline and 6 months]
- Change in Gut Microbiota Composition and Metabolites [Time frame: Baseline and 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Capital Medical University — Beijing
Identifiers
NCT: NCT07690384 · CNS-NNSRG2024-139