Krill Oil and Metformin in Women With PCOS and Metabolically Unhealthy Obesity

Sponsor
Firat University
Study ID
NCT07604870
Phase
PHASE2
Status
Completed

Conditions

  • Obesity, Metabolic
  • Polycystic Ovary Syndrome

Eligibility Criteria

Sex
FEMALE
Age
19 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Mar 1, 2023
Status verified
May 2026
Primary completion
Apr 30, 2024
Completion
Apr 30, 2024

Study Design

Enrollment
54 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Metformin Group (MET)
    Participants received Metformin Hydrochloride 1000 mg/day (single daily oral dose) for 8 weeks. No dietary supplement was added in this group.
  • Experimental: Krill Oil Group (KO)
    Participants received Krill Oil 2 g/day (1 g twice daily, orally) for 8 weeks. No pharmaceutical agent was administered in this group.
  • Experimental: Metformin + Krill Oil Group (METKO)
    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.
  • No Intervention: Control Group
    Participants received no intervention during the 8-week study period. They continued their habitual lifestyle without any dietary supplementation or pharmaceutical treatment.

Primary Outcome Measure

Change in Serum Adiponectin Level [ Time Frame: 8 weeks (Baseline and Week 8) ]

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