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NCT Number: NCT07690384

Effects of Functional Oils on Obesity With Mild Cognitive Impairment

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.

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Key information

Conditions

Obesity Body Weight Cognition Disorders Cognitive Dysfunction Mental Disorders Mild Cognitive Impairment Neurocognitive Disorders Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Conventional rapeseed 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.

Other names: Rapeseed oil-based DAG oil

Primary outcomes

  1. Change From Baseline in Cognitive Function

    Time frame: 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.

  2. Change From Baseline in Body Weight

    Time frame: Baseline and 6 months

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

  3. Change From Baseline in Body Fat Percentage

    Time frame: Baseline and 6 months

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

Secondary outcomes

  1. Change From Baseline in Visceral Fat Area

    Time frame: Baseline and 6 months

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

  2. Change From Baseline in Serum Lipid Concentrations

    Time frame: 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.

  3. Change in Gut Microbiota Composition and Metabolites

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiaxuan Tao

CONTACT

[email protected]

+86-15389510275

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

Interventional Study of Functional Oils Improving Obesity With Mild Cognitive Impairment Via Regulating White Adipose Tissue Browning

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 8, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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