Improvement of Fish Oil in Obesity With Mild Cognitive Impairment

NCT ID: NCT06992726

Last Updated: 2025-06-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2027-06-30

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.

Conditions

Obesity; Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

control group

Group Type: PLACEBO_COMPARATOR

Placebo intervention

Intervention Type: OTHER

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

Fish oil intervention group

Group Type: EXPERIMENTAL

Fish oil intervention

Intervention Type: 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.

Interventions

Fish oil intervention

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo intervention

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weiwei Ma

OTHER

Sponsor Role: lead

Responsible Party

Weiwei Ma

professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ruiqi Mu

Role: PRINCIPAL_INVESTIGATOR

Capital Medical University

Central Contacts

Weiwei Ma

Role: CONTACT

weiweima@ccmu.edu.cn

+8615810307505

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Z2023SY126

Identifier Type: -

Identifier Source: org_study_id