Effects of Functional Oils on Obesity With Mild Cognitive Impairment

NCT07690384 | Not Yet Recruiting

• 1 other identifier: CNS-NNSRG2024-139
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Mild Cognitive Impairment

Keywords

Functional Oil; Dietary Intervention

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in Cognitive Function

  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

  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

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

  Baseline and 6 months

Secondary Outcomes (3)

• Change From Baseline in Visceral Fat Area

  Baseline and 6 months

• Change From Baseline in Serum Lipid Concentrations

  Baseline and 6 months

• Change in Gut Microbiota Composition and Metabolites

  Baseline and 6 months

Study Arms (2)

RSO Group (Rapeseed Oil)

PLACEBO COMPARATOR

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)

DAG Group (Diacylglycerol Oil)

EXPERIMENTAL

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)

Interventions

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.

Also known as: Conventional rapeseed oil

RSO Group (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.

Also known as: Rapeseed oil-based DAG oil

DAG Group (Diacylglycerol Oil)

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Capital Medical University

Beijing, Beijing Municipality, 100069, China

Location

MeSH Terms

Conditions

Obesity; Cognitive Dysfunction

Interventions

Rapeseed Oil; Diglycerides

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Plant Oils; Oils; Lipids; Plant Preparations; Biological Products; Complex Mixtures; Glycerides

Study Officials

• Rong Xiao, PhD

  Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiaxuan Tao

CONTACT

+86-15389510275; taojxxx@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral student

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 8, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 8, 2026

Record last verified: 2026-07

Locations

CN (1)