Fish Oil
Dietary SupplementFor 12 months
NCT Number: NCT06424860
Women with Polycystic Ovary Syndrome (PCOS) have high testosterone levels which is associated with altered insulin-glucose metabolism and an adverse blood lipid profile, predisposing them to the development of Type II Diabetes and Cardiovascular Disease (CVD). This study will investigate the use of dietary fish oil supplementation as a safe and effective intervention, and as an adjunct therapy to standard of care treatment with metformin to improve heart health, blood lipids and insulin-glucose metabolism in women with PCOS, and those with PCOS and Type 2 Diabetes.
Interested in participating?
Request Info25 year–45 year
Female
Interventional
Phase 1
Human Nutrition Research Unit - Li Ka Shing Health Research Center, Edmonton, Alberta, Canada
OBJECTIVES The objective in this proposed study is to determine the effect of dietary fish oil supplementation with metformin compared to standard of care metformin-alone treatment for 12 months on plasma lipids and apoB- remnant lipoprotein metabolism, and atherosclerotic cardiovascular disease and cardiac function in high-risk overweight-obese young individuals with PCOS.
This study will provide evidence-based research on the efficacy of fish oil, in the form as an adjunct therapy to standard treatment with metformin, as a safe nutritional treatment to add to therapeutic guidelines to reduce early CVD risk in young women with PCOS.
Specific Objectives;
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-pregnancy, lactation
For 12 months
12 months
12 months
Time frame: 12 months
mm
Time frame: 12 months
mm
Time frame: 12 months
percent change in LVGLS
Time frame: 12 months
TG, LDL-C, HDL-C, non-HDL-C mmol/l
Time frame: 12 months
apob48 and apoB100 mg/l
Time frame: 12 months
mmol/l
Time frame: 12 months
nmol/l
Time frame: 12 months
pmol/l
Time frame: 12 months
mmol/l
Contact information is provided by the study sponsor or research team.
University of Alberta
Other
Dietary Fish Oil and Metformin Intervention for Heart Health in PCOS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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