Polycystic Ovary SyndromePhase 2NCT07604870
Krill Oil and Metformin in Women With PCOS and Metabolically Unhealthy Obesity
A Phase 2 study testing Metformin Hydrochloride 1000 MG and Krill Oil in people with Polycystic Ovary Syndrome and Obesity, Metabolic, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
This open-label, randomized, parallel-group pilot trial investigated the effects of krill oil, metformin, and their combination on adipokine profiles, cardiometabolic risk markers, and serum fatty acid composition in women with polycystic ovary syndrome (PCOS) and metabolically unhealthy obesity (MUO). Read more about this study
- Who is it for?
- Ages 19 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Obesity, Metabolic
- What is being tested?
- Metformin Hydrochloride 1000 MG and Krill Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 30 Apr 2024
- Phase
- Phase 2
- 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 19 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female sex, aged 19-40 years
- Diagnosis of Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria (at least 2 of 3: oligo/anovulation, clinical/biochemical hyperandrogenism, polycystic ovaries on ultrasound)
- Metabolically Unhealthy Obesity (MUO) defined by combined NCEP ATP-III/IDF criteria (waist circumference >88 cm plus ≥2 metabolic risk factors)
- BMI ≥ 30 kg/m2
- Willingness to provide written informed consent
Who cannot join
- Type 1 or Type 2 diabetes mellitus
- Thyroid disorders (uncontrolled hypo- or hyperthyroidism)
- Renal or hepatic disease
- Cardiovascular disease
- Use of oral contraceptives, insulin sensitizers, lipid-lowering drugs, or omega-3 supplements in the past 3 months
- Pregnancy or lactation
Show all 9Show fewer
- Allergy to fish or seafood (krill oil contraindication)
- Participation in another clinical trial
- Smokers or alcohol users
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Firat University, Faculty of Health Sciences, Department of Nutrition and Dietetics
Elâzığ, 23119
About this study
Official title: Effects of Krill Oil and Metformin on Cardiometabolic, Adipokine, Hormonal, and Fatty Acid Profiles in Women With Polycystic Ovary Syndrome and Metabolically Unhealthy Obesity: An Open-Label, Randomized, Parallel-Group Pilot Trial
This open-label, randomized, parallel-group pilot trial investigated the effects of krill oil, metformin, and their combination on adipokine profiles, cardiometabolic risk markers, and serum fatty acid composition in women with polycystic ovary syndrome (PCOS) and metabolically unhealthy obesity (MUO). Eligible women aged 19-40 years with PCOS according to Rotterdam criteria and MUO based on combined NCEP ATP-III/IDF criteria were allocated to three 8-week interventions: continuation of standard metformin therapy (MET), krill oil supplementation alone (KO), or metformin plus krill oil (METKO). Metformin users were stratified and randomized 1:1 to MET or METKO, while metformin-naive participants were assigned to KO. Krill oil (Superba Boost, Aker BioMarine) was administered at 2,000 mg/day (approximately 400 mg EPA and 240 mg DHA) and metformin at 1,000 mg/day. Primary outcomes were changes in serum adiponectin and neuregulin-4 (NRG-4) measured by ELISA. Secondary outcomes included anthropometric indices, fasting glucose, insulin, HOMA-IR, lipid profile, reproductive hormones, and detailed serum fatty acid profiling by GC-MS, as well as Mediterranean Diet Adherence Screener (MEDAS) scores. The trial aimed to provide preliminary evidence on whether adding krill oil to metformin therapy offers broader metabolic benefits than either intervention alone in women with PCOS and MUO.
- Conditions
- Polycystic Ovary Syndrome, Obesity, Metabolic
- Being tested
- Metformin Hydrochloride 1000 MG, Krill Oil
- Keywords
- krill oil, PCOS, omega-3 fatty acids, adipokine, metformin
- Medical subject headings
- Polycystic Ovary Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin Hydrochloride 1000 MGDrug
Metformin Hydrochloride 1000 mg/day (single daily oral dose) for 8 weeks. Metformin is a biguanide antidiabetic drug that improves insulin sensitivity and reduces hepatic glucose production. Used as standard treatment for PCOS-related insulin resistance and metabolic dysfunction.
Krill OilDietary supplement
Krill Oil 2 g/day (1 g twice daily, oral administration) for 8 weeks. Krill oil is a marine-derived omega-3 fatty acid supplement rich in EPA, DHA, and phospholipids with antioxidant astaxanthin. It has anti-inflammatory, lipid-modulating, and insulin-sensitizing properties relevant to PCOS and metabolic obesity management.
| Study group | Role | What they receive |
|---|---|---|
| Metformin Group (MET) | Experimental | Participants received Metformin Hydrochloride 1000 mg/day (single daily oral dose) for 8 weeks. No dietary supplement was added in this group. Receives: Drug: Metformin Hydrochloride 1000 MG |
| Krill Oil Group (KO) | Experimental | Participants received Krill Oil 2 g/day (1 g twice daily, orally) for 8 weeks. No pharmaceutical agent was administered in this group. Receives: Dietary Supplement: Krill Oil |
| Metformin + Krill Oil Group (METKO) | Experimental | Participants received Metformin Hydrochloride 1000 mg/day (single daily oral dose) combined with Krill Oil 2 g/day (1 g twice daily, orally) for 8 weeks. Receives: Drug: Metformin Hydrochloride 1000 MG; Dietary Supplement: Krill Oil |
| Control Group | No intervention | Participants received no intervention during the 8-week study period. They continued their habitual lifestyle without any dietary supplementation or pharmaceutical treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Adiponectin Level
Change in serum adiponectin concentration measured by ELISA at baseline and after 12 weeks of intervention. Adiponectin is an anti-inflammatory adipokine associated with insulin sensitivity and metabolic health.
Measured: 8 weeks (Baseline and Week 8)
Change in Serum Neuregulin-4 (NRG-4) Level
Change in serum neuregulin-4 (NRG-4) concentration measured by ELISA at baseline and after 12 weeks of intervention. NRG-4 is a novel adipokine linked to lipid metabolism, brown adipose tissue activity, and cardiometabolic health.
Measured: 8 weeks (Baseline and Week 8)
Secondary outcomes (2)
Change in Insulin Resistance (HOMA-IR)
Change in homeostatic model assessment of insulin resistance (HOMA-IR) calculated from fasting glucose and fasting insulin levels at baseline and 12 weeks.
Measured: 8 weeks (Baseline and Week 8)
Change in Lipid Profile (Total Cholesterol, LDL-C, HDL-C, Triglycerides)
Changes in fasting serum total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride concentrations measured at baseline and 12 weeks.
Measured: 8 weeks (Baseline and Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Mar 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Açık, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604870
- Sponsor's protocol ID
- FU_MAcik_PCOS_KO_2023
- Status last verified
- May 2026
- First submitted
- 17 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly. This is an academic pilot study and the data will be available upon reasonable request to the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Krill Oil and Metformin on Cardiometabolic, Adipokine, Hormonal, and Fatty Acid Profiles in Women With Polycystic Ovary Syndrome and Metabolically Unhealthy Obesity: An Open-Label, Randomized, Parallel-Group Pilot Trial
- ClinicalTrials.gov ID
- NCT07604870
- Acronym / sponsor ID
- FU_MAcik_PCOS_KO_2023
- Conditions
- Polycystic Ovary Syndrome, Obesity, Metabolic
- Keywords
- krill oil, PCOS, omega-3 fatty acids, adipokine, metformin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 22 May 2026 (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.
This open-label, randomized, parallel-group pilot trial investigated the effects of krill oil, metformin, and their combination on adipokine profiles, cardiometabolic risk markers, and serum fatty acid composition in women with polycystic ovary syndrome (PCOS) and metabolically unhealthy obesity (MUO). Eligible women aged 19-40 years with PCOS according to Rotterdam criteria and MUO based on combined NCEP ATP-III/IDF criteria were allocated to three 8-week interventions: continuation of standard metformin therapy (MET), krill oil supplementation alone (KO), or metformin plus krill oil (METKO). Metformin users were stratified and randomized 1:1 to MET or METKO, while metformin-naive participants were assigned to KO. Krill oil (Superba Boost, Aker BioMarine) was administered at 2,000 mg/day (approximately 400 mg EPA and 240 mg DHA) and metformin at 1,000 mg/day. Primary outcomes were changes in serum adiponectin and neuregulin-4 (NRG-4) measured by ELISA. Secondary outcomes included anthropometric indices, fasting glucose, insulin, HOMA-IR, lipid profile, reproductive hormones, and detailed serum fatty acid profiling by GC-MS, as well as Mediterranean Diet Adherence Screener (MEDAS) scores. The trial aimed to provide preliminary evidence on whether adding krill oil to metformin therapy offers broader metabolic benefits than either intervention alone in women with PCOS and MUO.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Metformin Group (MET) | Experimental | Drug: Metformin Hydrochloride 1000 MGParticipants received Metformin Hydrochloride 1000 mg/day (single daily oral dose) for 8 weeks. No dietary supplement was added in this group. |
| Krill Oil Group (KO) | Experimental | Dietary Supplement: Krill OilParticipants received Krill Oil 2 g/day (1 g twice daily, orally) for 8 weeks. No pharmaceutical agent was administered in this group. |
| Metformin + Krill Oil Group (METKO) | Experimental | Drug: Metformin Hydrochloride 1000 MG, Dietary Supplement: Krill OilParticipants received Metformin Hydrochloride 1000 mg/day (single daily oral dose) combined with Krill Oil 2 g/day (1 g twice daily, orally) for 8 weeks. |
| Control Group | No intervention | –Participants received no intervention during the 8-week study period. They continued their habitual lifestyle without any dietary supplementation or pharmaceutical treatment. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female sex, aged 19-40 years
- Diagnosis of Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria (at least 2 of 3: oligo/anovulation, clinical/biochemical hyperandrogenism, polycystic ovaries on ultrasound)
- Metabolically Unhealthy Obesity (MUO) defined by combined NCEP ATP-III/IDF criteria (waist circumference >88 cm plus ≥2 metabolic risk factors)
- BMI ≥ 30 kg/m2
- Willingness to provide written informed consent
Key exclusion criteria (9 listed)
- Type 1 or Type 2 diabetes mellitus
- Thyroid disorders (uncontrolled hypo- or hyperthyroidism)
- Renal or hepatic disease
- Cardiovascular disease
- Use of oral contraceptives, insulin sensitizers, lipid-lowering drugs, or omega-3 supplements in the past 3 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 |
|---|---|---|
| Metformin Hydrochloride 1000 MGMetformin Hydrochloride 1000 mg/day (single daily oral dose) for 8 weeks. Metformin is a biguanide antidiabetic drug that improves insulin sensitivity and reduces hepatic glucose production. Used as standard treatment for PCOS-related insulin resistance and metabolic dysfunction. | Drug | Metformin + Krill Oil Group (METKO), Metformin Group (MET) |
| Krill OilKrill Oil 2 g/day (1 g twice daily, oral administration) for 8 weeks. Krill oil is a marine-derived omega-3 fatty acid supplement rich in EPA, DHA, and phospholipids with antioxidant astaxanthin. It has anti-inflammatory, lipid-modulating, and insulin-sensitizing properties relevant to PCOS and metabolic obesity management. | Dietary supplement | Krill Oil Group (KO), Metformin + Krill Oil Group (METKO) |
Primary outcome
Change in Serum Adiponectin Level
Time frame: 8 weeks (Baseline and Week 8)
Change in serum adiponectin concentration measured by ELISA at baseline and after 12 weeks of intervention. Adiponectin is an anti-inflammatory adipokine associated with insulin sensitivity and metabolic health.
Change in Serum Neuregulin-4 (NRG-4) Level
Time frame: 8 weeks (Baseline and Week 8)
Change in serum neuregulin-4 (NRG-4) concentration measured by ELISA at baseline and after 12 weeks of intervention. NRG-4 is a novel adipokine linked to lipid metabolism, brown adipose tissue activity, and cardiometabolic health.
2 secondary outcomes
Change in Insulin Resistance (HOMA-IR)
Time frame: 8 weeks (Baseline and Week 8)
Change in Lipid Profile (Total Cholesterol, LDL-C, HDL-C, Triglycerides)
Time frame: 8 weeks (Baseline and Week 8)
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 22 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly. This is an academic pilot study and the data will be available upon reasonable request to the corresponding author.
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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 Phase 2 study testing Metformin Hydrochloride 1000 MG and Krill Oil in people with Polycystic Ovary Syndrome and Obesity, Metabolic, run by Firat University at 1 site in Turkey (Türkiye).
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 5 inclusion and 9 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 22 May 2026. 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 Turkey (Türkiye). 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in Serum Adiponectin Level (time frame: 8 weeks (Baseline and Week 8)). The study lists 2 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 22 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.