Improvement of Fish Oil in Obesity With Mild Cognitive Impairment

Weiwei Ma

Status and phase: Begins enrollment in 1 month; Phase 4

Conditions: Mild Cognitive Impairment; Obesity

Treatments: Other: Placebo intervention; Dietary Supplement: Fish oil intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06992726

Z2023SY126

Details and patient eligibility

About

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 2 g fish oil capsules); the placebo group took placebo (2 g/d), and the intervention period was 12 consecutive months. Differences in 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.

Enrollment: 88 estimated patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

88 participants in 2 patient groups, including a placebo group

control group

Placebo Comparator group

Treatment:

Other: Placebo intervention

Fish oil intervention group

Experimental group

Treatment:

Dietary Supplement: Fish oil intervention