ObesityNCT07690384
Effects of Functional Oils on Obesity With Mild Cognitive Impairment
A study testing Rapeseed Oil (RSO) and Diacylglycerol Oil (DAG Oil) in people with Obesity and Mild Cognitive Impairment, run by Capital Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Obesity, Mild Cognitive Impairment
- What is being tested?
- Rapeseed Oil (RSO) and Diacylglycerol Oil (DAG Oil)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jul 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Capital Medical University
Beijing, Beijing Municipality, 100069
Rong Xiao, PhD, +86-18611314617, xiaor22@ccmu.edu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Mild Cognitive Impairment
- Being tested
- Rapeseed Oil (RSO), Diacylglycerol Oil (DAG Oil)
- Keywords
- Functional Oil, Dietary Intervention
- Medical subject headings
- Obesity, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapeseed Oil (RSO)Dietary supplement
Also called Conventional rapeseed oil
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
Also called Rapeseed oil-based 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Diacylglycerol Oil (DAG Oil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: Baseline and 6 months
Secondary outcomes (3)
Change From Baseline in Visceral Fat Area
Change from baseline in visceral fat area measured by bioelectrical impedance analysis (InBody body composition analyzer).
Measured: Baseline and 6 months
Change From Baseline in Serum Lipid Concentrations
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.
Measured: Baseline and 6 months
Change in Gut Microbiota Composition and Metabolites
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.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiaxuan Tao, Capital Medical University
- Investigators
- Rong Xiao, PhD, Principal investigator, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690384
- Sponsor's protocol ID
- CNS-NNSRG2024-139
- Status last verified
- Jul 2026
- First submitted
- 29 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Study of Functional Oils Improving Obesity With Mild Cognitive Impairment Via Regulating White Adipose Tissue Browning
- ClinicalTrials.gov ID
- NCT07690384
- Acronym / sponsor ID
- CNS-NNSRG2024-139
- Conditions
- Obesity, Mild Cognitive Impairment
- Keywords
- Functional Oil, Dietary Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RSO Group (Rapeseed Oil) | Placebo comparator | Dietary Supplement: Rapeseed Oil (RSO)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. |
| DAG Group (Diacylglycerol Oil) | Experimental | Dietary Supplement: Diacylglycerol Oil (DAG 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. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapeseed Oil (RSO)Also: Conventional rapeseed oilA 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 | RSO Group (Rapeseed Oil) |
| Diacylglycerol Oil (DAG Oil)Also: Rapeseed oil-based DAG oilA 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. | Dietary supplement | DAG Group (Diacylglycerol Oil) |
Primary outcome
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.
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).
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).
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rong Xiao, PhD principal investigator
Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapeseed Oil (RSO) and Diacylglycerol Oil (DAG Oil) in people with Obesity and Mild Cognitive Impairment, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiaxuan Tao (+86-15389510275, taojxxx@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Cognitive Function (time frame: Baseline and 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.