Effects of Functional Oils on Obesity With Mild Cognitive Impairment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-75
SponsorCapital Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Meets the diagnostic criteria for obesity combined with mild cognitive impairment (MCI) (obesity: BMI ≥28.0 kg/m² 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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Rapeseed Oil (RSO)
Dietary supplementA 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 supplementA 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: RSO Group (Rapeseed Oil)Placebo comparator 1 intervention
Group B: DAG Group (Diacylglycerol Oil)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and 6 months2
Change From Baseline in Body Weight
Change from baseline in body weight (kg) measured by bioelectrical impedance analysis (InBody body composition analyzer).
Time frame
Baseline and 6 months3
Change From Baseline in Body Fat Percentage
Change from baseline in body fat percentage measured by bioelectrical impedance analysis (InBody body composition analyzer).
Time frame
Baseline and 6 monthsSecondary outcomes
1
Change From Baseline in Visceral Fat Area
Change from baseline in visceral fat area measured by bioelectrical impedance analysis (InBody body composition analyzer).
Time frame
Baseline and 6 months2
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.
Time frame
Baseline and 6 months3
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.
Time frame
Baseline and 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: