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

17. mai 2026 oppdatert av: Murat Açık, Firat University

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

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

54

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Tyrkia (Türkiye)
      • Elâzığ, Tyrkia (Türkiye), 23119
        • Firat University, Faculty of Health Sciences, Department of Nutrition and Dietetics

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: Metformin Hydrochloride 1000 MG
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.
Eksperimentell: 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.
Kosttilskudd: Krill 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.
Eksperimentell: 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.
Legemiddel: Metformin Hydrochloride 1000 MG
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.
Kosttilskudd: Krill 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.
Ingen inngripen: Control Group
Participants received no intervention during the 8-week study period. They continued their habitual lifestyle without any dietary supplementation or pharmaceutical treatment.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Serum Adiponectin Level
Tidsramme: 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.
8 weeks (Baseline and Week 8)
Change in Serum Neuregulin-4 (NRG-4) Level
Tidsramme: 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.
8 weeks (Baseline and Week 8)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Insulin Resistance (HOMA-IR)
Tidsramme: 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.
8 weeks (Baseline and Week 8)
Change in Lipid Profile (Total Cholesterol, LDL-C, HDL-C, Triglycerides)
Tidsramme: 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.
8 weeks (Baseline and Week 8)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Firat University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mars 2023

Primær fullføring (Faktiske)

30. april 2024

Studiet fullført (Faktiske)

30. april 2024

Datoer for studieregistrering

Først innsendt

17. mai 2026

Først innsendt som oppfylte QC-kriteriene

17. mai 2026

Først lagt ut (Faktiske)

22. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • FU_MAcik_PCOS_KO_2023

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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