Clinical trial · Interventional
Dietary Fish Oil Intervention in Polycystic Ovary Syndrome (PCOS)
Dietary Fish Oil Intervention in Polycystic Ovary Syndrome
NCT04116203CI-TRIAL-00086592PCOScompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective in this proposed study is to determine the effect of dietary fish oil supplementation compared to standard care metformin treatment, and fish oil in combination with metformin on plasma lipids and apoB-remnant lipoprotein metabolism in overweight-obese young women with PCOS.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lipid Metabolism Disorders | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fish Oil | Dietary Supplement | — | UNRESOLVED |
| Fish Oil and Metformin | Combination Product | — | UNRESOLVED |
| Metformin | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- Fish Oil
- description
- Fish oil capsules 1200mg 6 tablets/day 12 weeks
- interventionNames
- Dietary Supplement: Fish Oil
- type
- OTHER
- label
- Metformin
- description
- Metformin tablets (500 mg) 2/day 12 weeks
- interventionNames
- Drug: Metformin
- type
- OTHER
- label
- Fish Oil and Metformin
- description
- Combo of other 2 arms
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * Female * Age at time of enrollment \> 18 to \<30 years * Diagnosis of PCOS: clinical and/or biochemical hyperandrogenemia and menstrual dysfunction and the exclusion of other disorders. * Overweight-obese (BMI \>25 kg/m2) high-risk metabolically-resistant young women. * Elevated fasting plasma TG (\>150 mg/dL) and apoB48-remnant cholesterol lipoproteins (\>20 ug/ml). * Impaired insulin sensitivity (glucose 100-125 mg/dL and/or insulin \>15 (uM/ml); and * May be diagnosed with T2D (blood glucose \>126 mg/dL). Exclusion Criteria: * Pregnancy * Lactating women * Recent illness that the investigator determines to pose a potential risk for the participant * Concomitant medications that influence metabolism (e.g. statins) * Excessive alcohol consumption, as determined by the investigator.
References
Publications (1)
- RESULTVine DF, Wang Y, Jetha MM, Ball GD, Proctor SD. Impaired ApoB-Lipoprotein and Triglyceride Metabolism in Obese Adolescents With Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2017 Mar 1;102(3):970-982. doi: 10.1210/jc.2016-2854. PMID 27997268