PCOSPhase 1NCT06424860
Fish Oil, Metformin and Heart Health in PCOS
A Phase 1 study testing Fish oil, Metformin and Fish Oil and Metformin in people with PCOS and Cardiovascular Disease, run by University of Alberta at 3 sites in Canada.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- PCOS, Cardiovascular Disease, Atherosclerotic Cardiovascular Disease
- What is being tested?
- Fish oil, Metformin and Fish Oil and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 3 sitesCanada
- Study dates
- 1 Nov 2025to 30 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- diagnosis of PCOS
- overweight-obese (BMI >25 kg/m2)
- elevated fasting plasma TG (>150 mg/dL)
- and/or 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).
Who cannot join
- -pregnancy, lactation
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites, 3 recruiting
- Recruiting
Human Nutrition Research Unit - Li Ka Shing Health Research Center
Edmonton, Alberta, T6G 2E1
Donna Vine, PhD, 780-492-4393, dvine@ualberta.ca
Beate Sydora, PhD, 780-940-1476, bsydora@ualberta.ca
- Recruiting
Mazankowski Alberta Heart Institute
Edmonton, Alberta, T6G-2B7
Donna Vine, PhD, 780-492-4393, dvine@ualberta.ca
Beate Sydora, PhD, 780-940-1476, bsydora@ualberta.ca
- Recruiting
University of Alberta Hospital - Division of Endocrinology
Edmonton, Alberta, T6G-2B7
Beate Sydora, PhD, 7804920302, reoffice@ualberta.ca
Beate Sydora
About this study
Official title: Dietary Fish Oil and Metformin Intervention for Heart Health in PCOS
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.
Read the detailed description
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;
- To quantify carotid intimal medical thickness (cIMT) and plaque height before and after the intervention to assess the effect of fish oil supplementation combined with metformin standard of care on atherosclerotic cardiovascular disease and cardiac function.
- To determine the effects of dietary fish oil supplementation combined with metformin and metformin standard of care on fasting and non-fasting plasma TG, apoB48 and apoB100-lipoprotein concentrations, and cardiac function variables including left ventricular (LV) posterior wall thickness, LV ejection fraction.
- To assess the effect of dietary fish oil supplementation on insulin, glucose, and endocrine parameters.
- Conditions
- PCOS, Cardiovascular Disease, Atherosclerotic Cardiovascular Disease, Atherosclerotic Plaque, Cardiac Hypertrophy
- Being tested
- Fish oil, Metformin, Fish Oil and Metformin
- Medical subject headings
- Cardiovascular Diseases, Atherosclerosis, Plaque, Atherosclerotic, Cardiomegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish oilDietary supplement
For 12 months
MetforminDrug
12 months
Fish Oil and MetforminCombination product
12 months
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Active comparator | metformin (1500mg/d) and placebo (olive oil capsule) Receives: Drug: Metformin |
| Fishoil and metformin | Experimental | metformin (1500mg/d) and fish oil (4000mg/d) Receives: Dietary Supplement: Fish oil; Combination Product: Fish Oil and Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotid intimal medial thickness
mm
Measured: 12 months
carotid plaque height
mm
Measured: 12 months
Left ventricular global longitudinal strain (LVGLS)
percent change in LVGLS
Measured: 12 months
Secondary outcomes (6)
Blood lipids
TG, LDL-C, HDL-C, non-HDL-C mmol/l
Measured: 12 months
ApoB-lipoproteins
apob48 and apoB100 mg/l
Measured: 12 months
remnant-cholesterol
mmol/l
Measured: 12 months
Testosterone
nmol/l
Measured: 12 months
insulin
pmol/l
Measured: 12 months
glucose
mmol/l
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start1 Nov 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PCOSStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424860
- Sponsor's protocol ID
- 00141704
- Status last verified
- Dec 2025
- First submitted
- 29 Apr 2024
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan
Publications
Sydora B, Ghosh M, Chambers S, Haase A, Davenport M, Beaulieu C, Thompson R, Windram J, Becher H, Raggi P, Vine D. Effect of fish oil as an adjunct therapy to metformin on vascular and cardiac health in women with polyendocrine metabolic ovarian syndrome: protocol for a randomised, placebo-controlled clinical trial. BMJ Open. 2026 Sep 18;16(9):e124025. doi: 10.1136/bmjopen-2026-124025.
PubMed 42760081
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Fish Oil and Metformin Intervention for Heart Health in PCOS
- ClinicalTrials.gov ID
- NCT06424860
- Acronym / sponsor ID
- 00141704
- Conditions
- PCOS, Cardiovascular Disease, Atherosclerotic Cardiovascular Disease, Atherosclerotic Plaque, Cardiac Hypertrophy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 22 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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;
- To quantify carotid intimal medical thickness (cIMT) and plaque height before and after the intervention to assess the effect of fish oil supplementation combined with metformin standard of care on atherosclerotic cardiovascular disease and cardiac function.
- To determine the effects of dietary fish oil supplementation combined with metformin and metformin standard of care on fasting and non-fasting plasma TG, apoB48 and apoB100-lipoprotein concentrations, and cardiac function variables including left ventricular (LV) posterior wall thickness, LV ejection fraction.
- To assess the effect of dietary fish oil supplementation on insulin, glucose, and endocrine parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | Active comparator | Drug: Metforminmetformin (1500mg/d) and placebo (olive oil capsule) |
| Fishoil and metformin | Experimental | Dietary Supplement: Fish oil, Combination Product: Fish Oil and Metforminmetformin (1500mg/d) and fish oil (4000mg/d) |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- diagnosis of PCOS
- overweight-obese (BMI >25 kg/m2)
- elevated fasting plasma TG (>150 mg/dL)
- and/or 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).
Key exclusion criteria (1 listed)
- -pregnancy, lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish oilFor 12 months | Dietary supplement | Fishoil and metformin |
| Metformin12 months | Drug | Metformin |
| Fish Oil and Metformin12 months | Combination product | Fishoil and metformin |
Primary outcome
Carotid intimal medial thickness
Time frame: 12 months
mm
carotid plaque height
Time frame: 12 months
mm
Left ventricular global longitudinal strain (LVGLS)
Time frame: 12 months
percent change in LVGLS
6 secondary outcomes
Blood lipids
Time frame: 12 months
ApoB-lipoproteins
Time frame: 12 months
remnant-cholesterol
Time frame: 12 months
Testosterone
Time frame: 12 months
insulin
Time frame: 12 months
glucose
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Derived from this study: PubMed 42760081Sydora B, Ghosh M, Chambers S, Haase A, Davenport M, Beaulieu C, Thompson R, Windram J, Becher H, Raggi P, Vine D. Effect of fish oil as an adjunct therapy to metformin on vascular and cardiac health in women with polyendocrine metabolic ovarian syndrome: protocol for a randomised, placebo-controlled clinical trial. BMJ Open. 2026 Sep 18;16(9):e124025. doi: 10.1136/bmjopen-2026-124025.
- Individual participant dataSharing planned: No. no plan
Related trials for PCOS
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fish oil, Metformin and Fish Oil and Metformin in people with PCOS and Cardiovascular Disease, run by University of Alberta at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Donna Vine, PhD (780-492-4393, dvine@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carotid intimal medial thickness (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06424860, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.