Cognitive DeclineNCT06614374
Fish Oil for Cognitive Function, Sleep Quality, and Bone Density
A study testing Low-dose fish oil capsules, High-dose fish oil capsules and Refined olive oil in people with Cognitive Decline and Sleep, run by Jingjing Jiao at 1 site in China.
Trial summary
The Precision Nutritional Management for Diabetes trial (PNMD; NCT03708887) is a randomized clinical trial in 415 diabetic patients investigating whether taking daily dietary supplements of omega-3 fatty acids (1.5 or 3 grams) improves glucose and lipid homeostasis in Chinese diabetic patients. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Cognitive Decline, Sleep, Bone Mineral Density
- What is being tested?
- Low-dose fish oil capsules, High-dose fish oil capsules and Refined olive oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 415 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2020to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed type 2 diabetes according to WHO diagnostic criteria or those on the use of diabetic medications;
- Between 40 and 75 years old (postmenopausal women);
- Have never used n-3 PUFA supplements before or have stopped using them for more than six months.
Who cannot join
- Type 1 diabetes;
- Coronary heart disease, stroke, cancer, hepatic or kidney disease;
- Pregnancy or lactation;
- Allergy to fish;
- Have participated in other clinical trials in the last three months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of n-3 Fatty Acids on Cognitive Function, Sleep Quality, and Bone Mineral Density in Diabetic Patients: an Ancillary Study of the Precision Nutritional Management for Diabetes (PNMD) Trial
The Precision Nutritional Management for Diabetes trial (PNMD; NCT03708887) is a randomized clinical trial in 415 diabetic patients investigating whether taking daily dietary supplements of omega-3 fatty acids (1.5 or 3 grams) improves glucose and lipid homeostasis in Chinese diabetic patients. This ancillary study is being conducted among PNMD participants and will examine whether fish oil supplements affect A) cognitive function, B) sleep quality, and C) bone mineral density. Cognitive function, sleep quality, and bone mineral density will be evaluated at baseline and post-intervention. The Mini-Mental State Exams (MMSE) will be conducted to evaluate the cognitive function of participants. The Pittsburgh Sleep Quality Index (PSQI) will be calculated through questionnaires to evaluate sleep quality. The Dual-emission X-ray Absorptiometry (DXA) will be assessed to measure the bone density.
- Conditions
- Cognitive Decline, Sleep, Bone Mineral Density
- Being tested
- Low-dose fish oil capsules, High-dose fish oil capsules, Refined olive oil
- Keywords
- Fish oil, Omega-3 fatty acids, cognitive function, sleep quality, bone density
- Medical subject headings
- Cognitive Dysfunction, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose fish oil capsulesDietary supplement
Patients in the low-dose group will receive four fish-oil and refined olive oil mixed capsules containing 1.5 g of marine n-3 PUFAs per day.
High-dose fish oil capsulesDietary supplement
Patients in the high-dose group will receive four fish oil capsules containing 3 g of marine n-3 PUFAs (72% EPA and 28% DHA) per day.
Refined olive oilDietary supplement
Participants in the control group will receive 4 g refined olive oil daily
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Subjects will receive equivalent amounts of refined olive oil daily. Receives: Dietary Supplement: Refined olive oil |
| Low-dose fish oil group | Experimental | Subjects will receive four fish oil and refined olive oil mixed capsules containing 1.5 g of marine n-3 PUFAs (72% EPA and 28% DHA) per day Receives: Dietary Supplement: Low-dose fish oil capsules |
| High-dose fish oil group | Experimental | Subjects will receive four fish oil capsules containing 3 g of marine n-3 PUFAs (72% EPA and 28% DHA) per day Receives: Dietary Supplement: High-dose fish oil capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
The Dual-emission X-ray Absorptiometry (DXA) will be assessed to measure the bone mineral density at baseline and post-intervention.
Measured: Baseline and 1 year
Sleep quality
The Pittsburgh Sleep Quality Index (PSQI) will be calculated through questionnaires to evaluate sleep quality. The Changes in sleep quality will be quantified by the difference in PSQI scores between the baseline and the conclusion of the intervention period.
Measured: Baseline and 1 year
Cognitive function
The Mini-Mental State Exams (MMSE) will be conducted to evaluate the cognitive function of participants at both the start and end of the study. Changes in cognitive function will be quantified by the difference in MMSE scores between the baseline and the conclusion of the intervention period.
Measured: Baseline and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start10 Oct 2020
- Primary completion2 Jan 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jingjing Jiao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jingjing Jiao, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614374
- Sponsor's protocol ID
- RCT_N3_SUPPLE
- Status last verified
- Sep 2024
- First submitted
- 24 Sep 2024
- Last updated
- 13 Aug 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 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of n-3 Fatty Acids on Cognitive Function, Sleep Quality, and Bone Mineral Density in Diabetic Patients: an Ancillary Study of the Precision Nutritional Management for Diabetes (PNMD) Trial
- ClinicalTrials.gov ID
- NCT06614374
- Acronym / sponsor ID
- RCT_N3_SUPPLE
- Conditions
- Cognitive Decline, Sleep, Bone Mineral Density
- Keywords
- Fish oil, Omega-3 fatty acids, cognitive function, sleep quality, bone density
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 415 participants (actual)
- Lead sponsor
- Jingjing JiaoUniversity, hospital or other
- Study start
- 10 Oct 2020 (actual)
- Primary completion
- 2 Jan 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 26 Sep 2024 (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.
The Precision Nutritional Management for Diabetes trial (PNMD; NCT03708887) is a randomized clinical trial in 415 diabetic patients investigating whether taking daily dietary supplements of omega-3 fatty acids (1.5 or 3 grams) improves glucose and lipid homeostasis in Chinese diabetic patients. This ancillary study is being conducted among PNMD participants and will examine whether fish oil supplements affect A) cognitive function, B) sleep quality, and C) bone mineral density. Cognitive function, sleep quality, and bone mineral density will be evaluated at baseline and post-intervention. The Mini-Mental State Exams (MMSE) will be conducted to evaluate the cognitive function of participants. The Pittsburgh Sleep Quality Index (PSQI) will be calculated through questionnaires to evaluate sleep quality. The Dual-emission X-ray Absorptiometry (DXA) will be assessed to measure the bone density.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Dietary Supplement: Refined olive oilSubjects will receive equivalent amounts of refined olive oil daily. |
| Low-dose fish oil group | Experimental | Dietary Supplement: Low-dose fish oil capsulesSubjects will receive four fish oil and refined olive oil mixed capsules containing 1.5 g of marine n-3 PUFAs (72% EPA and 28% DHA) per day |
| High-dose fish oil group | Experimental | Dietary Supplement: High-dose fish oil capsulesSubjects will receive four fish oil capsules containing 3 g of marine n-3 PUFAs (72% EPA and 28% DHA) per day |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed type 2 diabetes according to WHO diagnostic criteria or those on the use of diabetic medications;
- Between 40 and 75 years old (postmenopausal women);
- Have never used n-3 PUFA supplements before or have stopped using them for more than six months.
Key exclusion criteria (5 listed)
- Type 1 diabetes;
- Coronary heart disease, stroke, cancer, hepatic or kidney disease;
- Pregnancy or lactation;
- Allergy to fish;
- Have participated in other clinical trials in the last three months.
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 |
|---|---|---|
| Low-dose fish oil capsulesPatients in the low-dose group will receive four fish-oil and refined olive oil mixed capsules containing 1.5 g of marine n-3 PUFAs per day. | Dietary supplement | Low-dose fish oil group |
| High-dose fish oil capsulesPatients in the high-dose group will receive four fish oil capsules containing 3 g of marine n-3 PUFAs (72% EPA and 28% DHA) per day. | Dietary supplement | High-dose fish oil group |
| Refined olive oilParticipants in the control group will receive 4 g refined olive oil daily | Dietary supplement | Control group |
Primary outcome
Bone mineral density
Time frame: Baseline and 1 year
The Dual-emission X-ray Absorptiometry (DXA) will be assessed to measure the bone mineral density at baseline and post-intervention.
Sleep quality
Time frame: Baseline and 1 year
The Pittsburgh Sleep Quality Index (PSQI) will be calculated through questionnaires to evaluate sleep quality. The Changes in sleep quality will be quantified by the difference in PSQI scores between the baseline and the conclusion of the intervention period.
Cognitive function
Time frame: Baseline and 1 year
The Mini-Mental State Exams (MMSE) will be conducted to evaluate the cognitive function of participants at both the start and end of the study. Changes in cognitive function will be quantified by the difference in MMSE scores between the baseline and the conclusion of the intervention period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-dose fish oil capsules, High-dose fish oil capsules and Refined olive oil in people with Cognitive Decline and Sleep, run by Jingjing Jiao at 1 site in China.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density (time frame: Baseline and 1 year). The study lists 3 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 13 Aug 2025; AzTrials last refreshed its copy on 3 Nov 2026.