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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
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 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.
Firat University, Faculty of Health Sciences, Department of Nutrition and Dietetics
Elâzığ, Turkey (Türkiye)
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.
Time frame: 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.
Time frame: 8 weeks (Baseline and Week 8)
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.
Time frame: 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.
Time frame: 8 weeks (Baseline and Week 8)
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