Clinical trial NCT06992726: Improvement of Fish Oil in Obesity With Mild Cognitive Impairment
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Obesity
Mild Cognitive Impairment
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 88
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Height, Waist
timeFrame: Baseline, 6 months, 12 months
measure: weight
timeFrame: Baseline, 6 months, 12 months
measure: Total Body Water
timeFrame: Baseline, 6 months, 12 months
measure: body protein, inorganic salts, and body fat
timeFrame: Baseline, 6 months, 12 months
measure: Appendicular skeletal muscle mass index
timeFrame: Baseline, 6 months, 12 months
measure: Cognitive function assessment
timeFrame: Baseline, 6 months, 12 months
measure: Dietary composition
timeFrame: Baseline
measure: Dietary Inflammation Index
timeFrame: Baseline
measure: Species and abundance of intestinal flora
timeFrame: Baseline, 6 months, 12 months
measure: Metabolite levels of intestinal flora
timeFrame: Baseline, 6 months, 12 months
measure: Plasma inflammatory factor levels
timeFrame: Baseline, 6 months, 12 months
measure: Erythrocyte Membrane n-3 PUFA Levels
timeFrame: Baseline, 6 months, 12 months
measure: Plasma Beige Lipid Marker Levels
timeFrame: Baseline, 6 months, 12 months
measure: Fecal Akkermansia abundance
timeFrame: Baseline, 6 months, 12 months
measure: Fecal Amuc_1100 expression levels
timeFrame: Baseline, 6 months, 12 months
measure: Detection of signaling pathway related indicators of plasma fat metabolism
timeFrame: Baseline, 6 months, 12 months
measure: Levels of lipopolysaccharide
timeFrame: Baseline, 6 months, 12 months
measure: Plasma lipid oxide concentrations
timeFrame: Baseline, 6 months, 12 months
measure: Levels of fatty acid synthetase
timeFrame: Baseline, 6 months, 12 months
Secondary outcomes:
measure: Blood lipids
timeFrame: Baseline, 6 months, 12 months
measure: Fasting blood glucose
timeFrame: Baseline, 6 months, 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Capital Medical University
name: Ruiqi Mu
role: PRINCIPAL_INVESTIGATOR
References: