Improvement of Fish Oil in Obesity With Mild Cognitive Impairment

Phase 4Not Yet RecruitingNCT06992726

Weiwei Ma88 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Obesity Mild Cognitive Impairment

Interventions

Fish oil interventionDIETARY_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.

Placebo interventionOTHER

Diet based on the principles of a balanced diet, taking placebo capsules with the same appearance and odor as the fish oil capsules.

Eligibility

Sex: ALLMin age: 35 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

Height, Waist

Measurement of the subject's height and waist circumference using a tape measure.

Time frame: Baseline, 6 months, 12 months

weight

The weight of the subjects was measured using a weighing scale.

Time frame: Baseline, 6 months, 12 months

Total Body Water

Measuring Total Body Water (L) with the InBody Body Composition Analyzer.

Time frame: 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)

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline, 6 months, 12 months

Metabolite levels of intestinal flora

HPLC-MS/MS

Time frame: Baseline, 6 months, 12 months

Plasma inflammatory factor levels

High-Throughput Liquid Protein Chip

Time frame: Baseline, 6 months, 12 months

Erythrocyte Membrane n-3 PUFA Levels

Gas Chromatography

Time frame: Baseline, 6 months, 12 months

Plasma Beige Lipid Marker Levels

Double antibody sandwich ELISA

Time frame: Baseline, 6 months, 12 months

Fecal Akkermansia abundance

qPCR

Time frame: Baseline, 6 months, 12 months

Fecal Amuc_1100 expression levels

Fecal Amuc\_1100 mRNA expression was detected using Realtime-PCR.

Time frame: Baseline, 6 months, 12 months

Detection of signaling pathway related indicators of plasma fat metabolism

Enzyme colorimetric method

Time frame: Baseline, 6 months, 12 months

Levels of lipopolysaccharide

Enzyme colorimetric method

Time frame: Baseline, 6 months, 12 months

Plasma lipid oxide concentrations

LC-MS/MS

Time frame: Baseline, 6 months, 12 months

Levels of fatty acid synthetase

Enzyme colorimetric method

Time frame: Baseline, 6 months, 12 months

Secondary Outcomes

Blood lipids

Enzyme colorimetric method

Time frame: Baseline, 6 months, 12 months

Fasting blood glucose

Hexokinase method

Time frame: Baseline, 6 months, 12 months

Central Contacts

Weiwei Ma

CONTACT

+8615810307505 weiweima@ccmu.edu.cn

Data from ClinicalTrials.gov

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