ObesityPhase 4NCT06992726
Improvement of Fish Oil in Obesity With Mild Cognitive Impairment
A Phase 4 study testing Fish oil intervention in people with Obesity and Mild Cognitive Impairment, run by Weiwei Ma.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Obesity, Mild Cognitive Impairment
- What is being tested?
- Fish oil intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 30 Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- Fish oil intervention, Placebo intervention
- Medical subject headings
- Obesity, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish oil interventionDietary 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 interventionOther
Diet based on the principles of a balanced diet, taking placebo capsules with the same appearance and odor as the fish oil capsules.
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | Not described Receives: Other: Placebo intervention |
| Fish oil intervention group | Experimental | Not described Receives: Dietary Supplement: Fish oil intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height, Waist
Measurement of the subject's height and waist circumference using a tape measure.
Measured: Baseline, 6 months, 12 months
weight
The weight of the subjects was measured using a weighing scale.
Measured: Baseline, 6 months, 12 months
Total Body Water
Measuring Total Body Water (L) with the InBody Body Composition Analyzer.
Measured: Baseline, 6 months, 12 months
body protein, inorganic salts, and body fat
Measurement of body protein, inorganic salts, and body fat using the InBody Body Composition Analyzer (kg)
Measured: Baseline, 6 months, 12 months
Appendicular skeletal muscle mass index
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).
Measured: Baseline, 6 months, 12 months
Cognitive function assessment
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.
Measured: Baseline, 6 months, 12 months
Dietary composition
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.
Measured: Baseline
Dietary Inflammation Index
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.
Measured: Baseline
Species and abundance of intestinal flora
Detection Methods:Fecal flora was detected by designing and amplifying sequences specific to B. anthropophilus and then applying RT-qPCR.
Measured: Baseline, 6 months, 12 months
Metabolite levels of intestinal flora
HPLC-MS/MS
Measured: Baseline, 6 months, 12 months
Plasma inflammatory factor levels
High-Throughput Liquid Protein Chip
Measured: Baseline, 6 months, 12 months
Erythrocyte Membrane n-3 PUFA Levels
Gas Chromatography
Measured: Baseline, 6 months, 12 months
Plasma Beige Lipid Marker Levels
Double antibody sandwich ELISA
Measured: Baseline, 6 months, 12 months
Fecal Akkermansia abundance
qPCR
Measured: Baseline, 6 months, 12 months
Fecal Amuc_1100 expression levels
Fecal Amuc_1100 mRNA expression was detected using Realtime-PCR.
Measured: Baseline, 6 months, 12 months
Detection of signaling pathway related indicators of plasma fat metabolism
Enzyme colorimetric method
Measured: Baseline, 6 months, 12 months
Levels of lipopolysaccharide
Enzyme colorimetric method
Measured: Baseline, 6 months, 12 months
Plasma lipid oxide concentrations
LC-MS/MS
Measured: Baseline, 6 months, 12 months
Levels of fatty acid synthetase
Enzyme colorimetric method
Measured: Baseline, 6 months, 12 months
Secondary outcomes (2)
Blood lipids
Enzyme colorimetric method
Measured: Baseline, 6 months, 12 months
Fasting blood glucose
Hexokinase method
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weiwei Ma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Weiwei Ma, Capital Medical University
- Investigators
- Ruiqi Mu, Principal investigator, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992726
- Sponsor's protocol ID
- Z2023SY126
- Status last verified
- Jun 2025
- First submitted
- 5 May 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06992726
- Acronym / sponsor ID
- Z2023SY126
- Conditions
- Obesity, Mild Cognitive Impairment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Weiwei MaUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Other: Placebo intervention |
| Fish oil intervention group | Experimental | Dietary Supplement: Fish oil intervention |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish oil interventionThe 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. | Dietary supplement | Fish oil intervention group |
| Placebo interventionDiet based on the principles of a balanced diet, taking placebo capsules with the same appearance and odor as the fish oil capsules. | Other | control group |
Primary outcome
Height, Waist
Time frame: Baseline, 6 months, 12 months
Measurement of the subject's height and waist circumference using a tape measure.
weight
Time frame: Baseline, 6 months, 12 months
The weight of the subjects was measured using a weighing scale.
Total Body Water
Time frame: Baseline, 6 months, 12 months
Measuring Total Body Water (L) with the InBody Body Composition Analyzer.
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)
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).
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.
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.
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.
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.
Metabolite levels of intestinal flora
Time frame: Baseline, 6 months, 12 months
HPLC-MS/MS
Plasma inflammatory factor levels
Time frame: Baseline, 6 months, 12 months
High-Throughput Liquid Protein Chip
Erythrocyte Membrane n-3 PUFA Levels
Time frame: Baseline, 6 months, 12 months
Gas Chromatography
Plasma Beige Lipid Marker Levels
Time frame: Baseline, 6 months, 12 months
Double antibody sandwich ELISA
Fecal Akkermansia abundance
Time frame: Baseline, 6 months, 12 months
qPCR
Fecal Amuc_1100 expression levels
Time frame: Baseline, 6 months, 12 months
Fecal Amuc_1100 mRNA expression was detected using Realtime-PCR.
Detection of signaling pathway related indicators of plasma fat metabolism
Time frame: Baseline, 6 months, 12 months
Enzyme colorimetric method
Levels of lipopolysaccharide
Time frame: Baseline, 6 months, 12 months
Enzyme colorimetric method
Plasma lipid oxide concentrations
Time frame: Baseline, 6 months, 12 months
LC-MS/MS
Levels of fatty acid synthetase
Time frame: Baseline, 6 months, 12 months
Enzyme colorimetric method
2 secondary outcomes
Blood lipids
Time frame: Baseline, 6 months, 12 months
Fasting blood glucose
Time frame: Baseline, 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ruiqi Mu principal investigator
Capital Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fish oil intervention in people with Obesity and Mild Cognitive Impairment, run by Weiwei Ma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weiwei Ma (+8615810307505, weiweima@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Height, Waist (time frame: Baseline, 6 months, 12 months). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.