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Eighty-eight patients with obesity with mild cognitive impairment（MCI） from the Multicenter Nutrition and Chronic Disease Cohort, who met the inclusion and exclusion criteria, were selected as study subjects and randomly divided into 2 groups, i.e., the placebo group and the n-3 PUFA intervention group. Subjects in the intervention group were given supplemental n-3 PUFA (supplied in 1.36 g fish oil capsules); the placebo group took placebo (1.36 g/d), and the intervention period was 12 consecutive months. General information, dietary intake, body composition, exercise, overall cognitive function and multidimensional cognitive function, abundance of Mycobacterium avium and its metabolites acetic acid and propionic acid content, beige adiposity markers, inflammation-related factors, and lipid metabolism were collected at baseline, at the end of 6 months and at the end of 12 months of the intervention, respectively, and the adherence of the two groups of subjects was also assessed. To analyze the effects of n-3 PUFA intervention on cognitive function in patients with obesity with MCI and to explore the possible mechanisms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Placebo Comparator |
| |
| Fish oil intervention group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fish oil intervention | Dietary Supplement | The diet was based on the principles of a balanced diet, and subjects in this group were additionally supplemented with n-3 PUFA (provided as 1.36 g fish oil capsules), with the rest of the intervention being the same as in the control group. |
| Measure | Description | Time Frame |
|---|---|---|
| Height, Waist | Measurement of the subject's height and waist circumference using a tape measure. | Baseline, 6 months, 12 months |
| weight | The weight of the subjects was measured using a weighing scale. | Baseline, 6 months, 12 months |
| Total Body Water | Measuring Total Body Water (L) with the InBody Body Composition Analyzer. | Baseline, 6 months, 12 months |
| body protein, inorganic salts, and body fat | Measurement of body protein, inorganic salts, and body fat using the InBody Body Composition Analyzer (kg) | Baseline, 6 months, 12 months |
| Appendicular skeletal muscle mass index | Skeletal muscle mass of the extremities is the sum of the muscle mass of both upper and lower extremity skeletal muscles, which was measured using a body composition meter. The appendicular skeletal muscle mass index (ASMI) is the mass of the skeletal muscles of the extremities divided by the square of the height (kg/m2). | Baseline, 6 months, 12 months |
| Cognitive function assessment | Cognitive function was assessed using the Montreal Cognitive Assessment (MoCA) scale, which is a 30-point scale that includes multiple dimensions of cognitive functioning, including visuospatial and executive functioning, naming, memory, attention, language, abstraction, delayed recall, and orientation. The MCI diagnostic criteria were: <6 years of education, MoCA score ≤19; >7 years of education but ≤12 years, MoCA ≤22; >12 years of education, MoCA ≤24. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood lipids | Enzyme colorimetric method | Baseline, 6 months, 12 months |
| Fasting blood glucose | Hexokinase method | Baseline, 6 months, 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weiwei Ma | Contact | +8615810307505 | weiweima@ccmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ruiqi Mu | Capital Medical University | Principal Investigator |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2025 | May 14, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 1, 2025 | May 14, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Placebo intervention | Other | Diet based on the principles of a balanced diet, taking placebo capsules with the same appearance and odor as the fish oil capsules. |
|
| Baseline, 6 months, 12 months |
| Dietary composition | The food frequency questionnaire (FFQ) was used for the survey assessment. With reference to the FFQ questionnaire used in the Nutrition and Health Status Survey of Chinese Residents, a total of 72 food inquiry entries in 11 food groups were included, with a focus on n-3 PUFA-rich foods, as well as the intake of edible oils and condiments. Auxiliary survey tools such as the Retrospective Dietary Survey Auxiliary Atlas were used to help respondents recall. The Standardized Version of the Chinese Food Composition Table (6th Edition) was used to calculate the energy and nutrient intake of the population, including the intake of dietary fatty acids. | Baseline |
| Dietary Inflammation Index | The dietary inflammatory index (DI) for each dietary component/nutrient was calculated separately for each individual based on the mean and standard deviation of the per capita daily intake of each dietary component or nutrient and the corresponding dietary effect index of each component.If a food increases the level of pro-inflammatory factors or decreases the level of anti-inflammatory factors, it is labeled as "+1" for a pro-inflammatory effect; conversely, it is assigned "-1" for an anti-inflammatory effect. If there was no significant change in inflammatory markers, "0" was assigned as no pro/anti-inflammatory effect. The final DI score for each food was accumulated to obtain an overall dietary DI score for the individual; the higher the total DI score, the greater the pro-inflammatory effect of the diet, and conversely, the greater the anti-inflammatory effect. | Baseline |
| Species and abundance of intestinal flora | Detection Methods:Fecal flora was detected by designing and amplifying sequences specific to B. anthropophilus and then applying RT-qPCR. | Baseline, 6 months, 12 months |
| Metabolite levels of intestinal flora | HPLC-MS/MS | Baseline, 6 months, 12 months |
| Plasma inflammatory factor levels | High-Throughput Liquid Protein Chip | Baseline, 6 months, 12 months |
| Erythrocyte Membrane n-3 PUFA Levels | Gas Chromatography | Baseline, 6 months, 12 months |
| Plasma Beige Lipid Marker Levels | Double antibody sandwich ELISA | Baseline, 6 months, 12 months |
| Fecal Akkermansia abundance | qPCR | Baseline, 6 months, 12 months |
| Fecal Amuc_1100 expression levels | Fecal Amuc_1100 mRNA expression was detected using Realtime-PCR. | Baseline, 6 months, 12 months |
| Detection of signaling pathway related indicators of plasma fat metabolism | Enzyme colorimetric method | Baseline, 6 months, 12 months |
| Levels of lipopolysaccharide | Enzyme colorimetric method | Baseline, 6 months, 12 months |
| Plasma lipid oxide concentrations | LC-MS/MS | Baseline, 6 months, 12 months |
| Levels of fatty acid synthetase | Enzyme colorimetric method | Baseline, 6 months, 12 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |