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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin Hydrochloride 1000 MG | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 8 weeks (Baseline and Week 8) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks (Baseline and Week 8) |
| Change in Lipid Profile (Total Cholesterol, LDL-C, HDL-C, Triglycerides) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Firat University, Faculty of Health Sciences, Department of Nutrition and Dietetics | Elâzığ | 23119 | Turkey (Türkiye) |
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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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Krill Oil | Dietary 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. |
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Changes in fasting serum total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride concentrations measured at baseline and 12 weeks. |
| 8 weeks (Baseline and Week 8) |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |