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NCT Number: NCT06992726

Improvement of Fish Oil in Obesity With Mild Cognitive Impairment

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.

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Key information

Conditions

Obesity Body Weight Cognition Disorders Cognitive Dysfunction Mental Disorders Mild Cognitive Impairment Neurocognitive Disorders Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fish oil intervention

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.

Placebo intervention

Other

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

Primary outcomes

  1. Height, Waist

    Time frame: Baseline, 6 months, 12 months

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

  2. weight

    Time frame: Baseline, 6 months, 12 months

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

  3. Total Body Water

    Time frame: Baseline, 6 months, 12 months

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

  4. body protein, inorganic salts, and body fat

    Time frame: Baseline, 6 months, 12 months

    Measurement of body protein, inorganic salts, and body fat using the InBody Body Composition Analyzer (kg)

  5. Appendicular skeletal muscle mass index

    Time frame: Baseline, 6 months, 12 months

    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).

  6. Cognitive function assessment

    Time frame: Baseline, 6 months, 12 months

    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.

  7. Dietary composition

    Time frame: Baseline

    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.

  8. Dietary Inflammation Index

    Time frame: Baseline

    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.

  9. Species and abundance of intestinal flora

    Time frame: Baseline, 6 months, 12 months

    Detection Methods:Fecal flora was detected by designing and amplifying sequences specific to B. anthropophilus and then applying RT-qPCR.

  10. Metabolite levels of intestinal flora

    Time frame: Baseline, 6 months, 12 months

    HPLC-MS/MS

  11. Plasma inflammatory factor levels

    Time frame: Baseline, 6 months, 12 months

    High-Throughput Liquid Protein Chip

  12. Erythrocyte Membrane n-3 PUFA Levels

    Time frame: Baseline, 6 months, 12 months

    Gas Chromatography

  13. Plasma Beige Lipid Marker Levels

    Time frame: Baseline, 6 months, 12 months

    Double antibody sandwich ELISA

  14. Fecal Akkermansia abundance

    Time frame: Baseline, 6 months, 12 months

    qPCR

  15. Fecal Amuc_1100 expression levels

    Time frame: Baseline, 6 months, 12 months

    Fecal Amuc_1100 mRNA expression was detected using Realtime-PCR.

  16. Detection of signaling pathway related indicators of plasma fat metabolism

    Time frame: Baseline, 6 months, 12 months

    Enzyme colorimetric method

  17. Levels of lipopolysaccharide

    Time frame: Baseline, 6 months, 12 months

    Enzyme colorimetric method

  18. Plasma lipid oxide concentrations

    Time frame: Baseline, 6 months, 12 months

    LC-MS/MS

  19. Levels of fatty acid synthetase

    Time frame: Baseline, 6 months, 12 months

    Enzyme colorimetric method

Secondary outcomes

  1. Blood lipids

    Time frame: Baseline, 6 months, 12 months

    Enzyme colorimetric method

  2. Fasting blood glucose

    Time frame: Baseline, 6 months, 12 months

    Hexokinase method

Study contacts

Contact information is provided by the study sponsor or research team.

Weiwei Ma

CONTACT

[email protected]

+8615810307505

Sponsors and collaborators

Lead sponsor

Weiwei Ma

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 28, 2025
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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