Improvement of Fish Oil in Obesity With Mild Cognitive Impairment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fish oil intervention, Placebo intervention.
- Who it may be relevant to
- Registry conditions: Obesity, Mild Cognitive Impairment. Basic parameters: 35 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
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.
Interventions
- Dietary supplement 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. - Other 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.
Primary outcome measures
- Height, Waist [Time frame: Baseline, 6 months, 12 months]
- weight [Time frame: Baseline, 6 months, 12 months]
- Total Body Water [Time frame: Baseline, 6 months, 12 months]
- body protein, inorganic salts, and body fat [Time frame: Baseline, 6 months, 12 months]
- Appendicular skeletal muscle mass index [Time frame: Baseline, 6 months, 12 months]
- Cognitive function assessment [Time frame: Baseline, 6 months, 12 months]
- Dietary composition [Time frame: Baseline]
- Dietary Inflammation Index [Time frame: Baseline]
- Species and abundance of intestinal flora [Time frame: Baseline, 6 months, 12 months]
- Metabolite levels of intestinal flora [Time frame: Baseline, 6 months, 12 months]
Secondary outcome measures (2)
- Blood lipids [Time frame: Baseline, 6 months, 12 months]
- Fasting blood glucose [Time frame: Baseline, 6 months, 12 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06992726 · Z2023SY126