NCT07604870CompletedPhase 2
Krill Oil and Metformin in Women With PCOS and Metabolically Unhealthy Obesity
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
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 54 (actual)
- First submitted
- 17 May 2026
- Start date
- 1 Mar 2023
- Primary completion date
- 30 Apr 2024
- Lead sponsor
- Firat University
- Diseases
- Obesity
- NCT number
- NCT07604870
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 54
- From 1 Mar 2023 to the primary completion date, 30 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of oral contraceptives, insulin sensitizers, lipid-lowering drugs, or omega-3 supplements in the past 3 months
Other illness
- Type 1 or Type 2 diabetes mellitus
- Thyroid disorders (uncontrolled hypo- or hyperthyroidism)
- Renal or hepatic disease
- Cardiovascular disease
- Allergy to fish or seafood (krill oil contraindication)
Other
- Pregnancy or lactation
- Participation in another clinical trial
- Smokers or alcohol users
Who the study is looking for
- 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
Age in the registry: 19 years to 40 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Firat University, Faculty of Health Sciences, Department of Nutrition and Dietetics Coordinator of this site? Confirm its status | Elâzığ | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.