Effects of Functional Oils on Obesity With Mild Cognitive Impairment

July 5, 2026 updated by: Jiaxuan Tao, Capital Medical University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100069
        • Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: RSO Group (Rapeseed Oil)
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.
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.
Other Names:
  • Conventional rapeseed oil
Experimental: DAG Group (Diacylglycerol Oil)
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.
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.
Other Names:
  • Rapeseed oil-based DAG oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 6 months
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).
Baseline and 6 months
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).
Baseline and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline and 6 months
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.
Baseline and 6 months
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.
Baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Capital Medical University

Investigators

  • Principal Investigator: Rong Xiao, PhD, Capital Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

June 29, 2026

First Submitted That Met QC Criteria

July 5, 2026

First Posted (Actual)

July 8, 2026

Study Record Updates

Last Update Posted (Actual)

July 8, 2026

Last Update Submitted That Met QC Criteria

July 5, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNS-NNSRG2024-139

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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