Mechanisms of n-3 Polyunsaturated Fatty Acids Promoting White Fat Beige Coloration to Improve Obesity With Cognitive Impairment by Regulating Intestinal Bacteriophages and Their Metabolites
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 88
- 主要终点
- Plasma Beige Lipid Marker Levels
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria of obesity and MCI;
- •Age between 35 and 80 years old;
- •No dieting or stop dieting in the last 3 months, no fish oil supplements, or willing to stop self-administration of fish oil 3 months before the intervention;
- •Voluntarily participate in the program with informed consent, and sign the informed consent form.
排除标准
- •Those with neuropsychiatric disorders such as stroke, epilepsy, or schizophrenia;
- •Those with cognitive impairment caused by depression, thyroid disease, traumatic brain injury, drug or alcohol intoxication;
- •Those with a history of cerebrovascular disease or cognitive impairment caused by severe cardiac, hepatic, pulmonary, or renal impairment;
- •Those who are complete vegetarians and are unable to comply with the balanced dietary pattern;
- •Those who suffer from severe angina pectoris, asthmatic bronchitis, severe infections , systemic lupus erythematosus, malignant tumors, and other diseases that may affect one's dietary habits and life;
- •Coeliac disease with lipid malabsorption.
研究组 & 干预措施
control group
干预措施: Placebo intervention (Other)
Fish oil intervention group
干预措施: Fish oil intervention (Dietary Supplement)
结局指标
主要结局
Plasma Beige Lipid Marker Levels
时间窗: Baseline, 6 months, 12 months
Double antibody sandwich ELISA
Levels of fatty acid synthetase
时间窗: Baseline, 6 months, 12 months
Enzyme colorimetric method
Height, Waist
时间窗: Baseline, 6 months, 12 months
Measurement of the subject's height and waist circumference using a tape measure.
weight
时间窗: Baseline, 6 months, 12 months
The weight of the subjects was measured using a weighing scale.
Total Body Water
时间窗: Baseline, 6 months, 12 months
Measuring Total Body Water (L) with the InBody Body Composition Analyzer.
Species and abundance of intestinal flora
时间窗: Baseline, 6 months, 12 months
Detection Methods:Fecal flora was detected by designing and amplifying sequences specific to B. anthropophilus and then applying RT-qPCR.
Metabolite levels of intestinal flora
时间窗: Baseline, 6 months, 12 months
HPLC-MS/MS
Plasma inflammatory factor levels
时间窗: Baseline, 6 months, 12 months
High-Throughput Liquid Protein Chip
body protein, inorganic salts, and body fat
时间窗: Baseline, 6 months, 12 months
Measurement of body protein, inorganic salts, and body fat using the InBody Body Composition Analyzer (kg)
Erythrocyte Membrane n-3 PUFA Levels
时间窗: Baseline, 6 months, 12 months
Gas Chromatography
Fecal Akkermansia abundance
时间窗: Baseline, 6 months, 12 months
qPCR
Fecal Amuc_1100 expression levels
时间窗: Baseline, 6 months, 12 months
Fecal Amuc_1100 mRNA expression was detected using Realtime-PCR.
Detection of signaling pathway related indicators of plasma fat metabolism
时间窗: Baseline, 6 months, 12 months
Enzyme colorimetric method
Levels of lipopolysaccharide
时间窗: Baseline, 6 months, 12 months
Enzyme colorimetric method
Plasma lipid oxide concentrations
时间窗: Baseline, 6 months, 12 months
LC-MS/MS
Appendicular skeletal muscle mass index
时间窗: Baseline, 6 months, 12 months
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).
Cognitive function assessment
时间窗: Baseline, 6 months, 12 months
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.
Dietary composition
时间窗: Baseline
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.
Dietary Inflammation Index
时间窗: Baseline
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.
次要结局
- Blood lipids(Baseline, 6 months, 12 months)
- Fasting blood glucose(Baseline, 6 months, 12 months)
研究者
Weiwei Ma
professor
Capital Medical University