Fish Oil + Metformin for Polycystic Ovarian Syndrome

Recruiting at 2 trial locations

Overseen By Donna Vine, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Phase 1

Sponsor: University of Alberta

Must be taking: Metformin

Disqualifiers: Pregnancy, Lactation

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

146 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether adding fish oil to metformin, a medication commonly used for type 2 diabetes, can help women with Polycystic Ovary Syndrome (PCOS) improve heart health and blood sugar levels. PCOS can cause high testosterone and insulin issues, increasing the risk of diabetes and heart problems. The study will compare metformin alone with metformin plus fish oil to determine which is more effective. Suitable participants have PCOS, are overweight, and have blood sugar or cholesterol issues. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, since it involves metformin, you may need to continue taking it if it's part of your current treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining fish oil and metformin might be safe and beneficial for young women with PCOS. In a small study involving 29 women, this combination lowered triglycerides, which are fats in the blood that can harm heart health. The study also observed a decrease in ApoB remnants, particles in the blood linked to cholesterol and heart disease.

Fish oil often supports heart health and is generally well-tolerated, with only minor side effects like a fishy aftertaste or an upset stomach reported by some. Metformin, a medication commonly used to treat diabetes, is also known for its safety in improving insulin levels and blood sugar.

While these findings are promising, remember that this trial is in the early stages. Much remains to be learned about the combination's tolerance, but early results are encouraging. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike standard treatments for Polycystic Ovarian Syndrome (PCOS) that often involve just metformin or hormonal therapies, this new approach pairs metformin with high-dose fish oil. Researchers are excited about this combination because fish oil is rich in omega-3 fatty acids, which have anti-inflammatory properties that might enhance metformin's effectiveness. This dual-action strategy not only targets insulin resistance, a common issue in PCOS, but may also address inflammation, providing a comprehensive treatment that could offer better symptom management.

What evidence suggests that this trial's treatments could be effective for PCOS?

This trial will compare the effects of metformin alone with a combination of fish oil and metformin for women with Polycystic Ovary Syndrome (PCOS). Research has shown that taking fish oil with metformin can improve heart health and blood fat levels in women with PCOS. Studies suggest that this combination can lower triglycerides and ApoB-remnants, both linked to heart disease. Some evidence indicates it may also reduce testosterone levels, which benefits women with PCOS. This combination shows promise for addressing abnormal blood fat levels and improving insulin and glucose management. Overall, these findings suggest that adding fish oil to metformin may offer extra benefits for women managing PCOS. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for women with PCOS who are overweight or obese, have high fasting triglycerides or remnant cholesterol lipoproteins, and impaired insulin sensitivity. It may also include those diagnosed with Type 2 Diabetes.

Inclusion Criteria

My BMI is over 25, indicating I am overweight or obese.

My fasting blood fat levels are high.

My apoB48-remnant cholesterol levels are above 20 ug/ml.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive metformin and either fish oil or placebo for 12 months to assess effects on cardiovascular and metabolic health

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fish Oil
• Metformin

Trial Overview

The study tests the effectiveness of fish oil supplements alone and combined with Metformin to improve heart health, blood lipids, and insulin-glucose metabolism in women with PCOS.

How Is the Trial Designed?

Group I: Fishoil and metformin Experimental Treatment 2 Interventions

metformin (1500mg/d) and fish oil (4000mg/d)

Group II: Metformin Active Control 1 Intervention

metformin (1500mg/d) and placebo (olive oil capsule)

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Heart and Stroke Foundation of Canada

Collaborator

Trials

131

Recruited

72,600+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8282216/

A Pilot Trial: Fish Oil and Metformin Effects on ApoB ...

Evidence to date suggests that FO supplementation may reduce fasting plasma TG in PCOS women [45-50]. However, the efficacy of FO or combination FO-metformin ...

2.

pcos.together.ualberta.ca

pcos.together.ualberta.ca/current-studies/fish-oil-metformin-study/

Fish Oil and Metformin Improves Blood Lipids

Fish oil supplementation alone or in combination with metformin may be an option to improve testosterone levels and bad fats that cause cardiovascular disease ...

3.

endocrine-abstracts.org

endocrine-abstracts.org/ea/0070/ea0070aep402

Fish oil and metformin combination to target dyslipidemia ...

Results: FO + Metformin treatment significantly reduced fasting plasma TG from baseline compared to other treatment groups (Combination 2.45 ± 0.43 vs 1.64 ± ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06424860

Fish Oil, Metformin and Heart Health in PCOS

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 ...

5.

hcplive.com

hcplive.com/view/combination-fish-oil-and-metformin-could-help-alleviate-burden-of-dyslipidemia-in-young-women-with-polycystic-ovary-syndrome

Combination of Fish Oil and Metformin Could Help ...

A pilot trial in 29 women suggests a combination of metformin and high dose fish oil could reduce triglycerides and ApoB-remnants among young women with ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11397015/

Role of Omega-3 Fatty Acids in Improving Metabolic ...

Several clinical trials showed that n-3 PUFAs can improve components of metabolic syndrome in women with PCOS.

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S2161831322000163

Nutritional Supplements and Complementary Therapies in ...

Supplementation with individual nutrients and complementary therapies may be beneficial in improving health outcomes in women with PCOS, by influencing key ...