Polycystic Ovary Syndrome, Obesity, Metabolic
Conditions
Keywords
krill oil, PCOS, omega-3 fatty acids, adipokine, metformin
Brief 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). 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.
Interventions
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.
DIETARY_SUPPLEMENTKrill Oil
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.
Sponsors
Firat University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Female sex, aged 19-40 years 2. Diagnosis of Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria (at least 2 of 3: oligo/anovulation, clinical/biochemical hyperandrogenism, polycystic ovaries on ultrasound) 3. Metabolically Unhealthy Obesity (MUO) defined by combined NCEP ATP-III/IDF criteria (waist circumference \>88 cm plus ≥2 metabolic risk factors) 4. BMI ≥ 30 kg/m2 5. Willingness to provide written informed consent
Exclusion criteria
1. Type 1 or Type 2 diabetes mellitus 2. Thyroid disorders (uncontrolled hypo- or hyperthyroidism) 3. Renal or hepatic disease 4. Cardiovascular disease 5. Use of oral contraceptives, insulin sensitizers, lipid-lowering drugs, or omega-3 supplements in the past 3 months 6. Pregnancy or lactation 7. Allergy to fish or seafood (krill oil contraindication) 8. Participation in another clinical trial 9. Smokers or alcohol users
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum Adiponectin Level | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Insulin Resistance (HOMA-IR) | 8 weeks (Baseline and Week 8) | Change in homeostatic model assessment of insulin resistance (HOMA-IR) calculated from fasting glucose and fasting insulin levels at baseline and 12 weeks. |
| Change in Lipid Profile (Total Cholesterol, LDL-C, HDL-C, Triglycerides) | 8 weeks (Baseline and Week 8) | Changes in fasting serum total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride concentrations measured at baseline and 12 weeks. |
Countries
Turkey (Türkiye)
Outcome results
None listed