Clinical trial

Effects of Functional Oils on Obesity With Mild Cognitive Impairment

Opening soon · Not applicable · 1 countries · Registry ID NCT07690384

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age45 Years to 75 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity, Mild Cognitive Impairment

Full registry 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

Treatments and study arms

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.

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.

Primary outcomes

Change From Baseline in Cognitive FunctionBaseline 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 WeightBaseline 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 PercentageBaseline and 6 months

Change from baseline in body fat percentage measured by bioelectrical impedance analysis (InBody body composition analyzer).

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Capital Medical University🇨🇳 Beijing, Beijing Municipality, China
Rong Xiao, PhDContact