Polycystic Ovary SyndromePhase 1PCOSNCT04116203
Dietary Fish Oil Intervention in Polycystic Ovary Syndrome (PCOS)
A Phase 1 study testing Metformin, Fish Oil and Metformin and Fish Oil in people with Polycystic Ovary Syndrome and Lipid Metabolism Disorders, run by University of Alberta at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Lipid Metabolism Disorders
- What is being tested?
- Metformin, Fish Oil and Metformin and Fish Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesCanada
- Study dates
- 30 Jun 2016to 12 Nov 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
9-111 Endocrinology Department, UofA Hospital
Edmonton, Alberta, T6G 2B7
2-004 Li Ka Shing Centre, UofA
Edmonton, Alberta, T6G 2E1
About this study
Official title: Dietary Fish Oil Intervention in Polycystic Ovary Syndrome
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.
Read the detailed description
Specific Objectives;
- To determine the effect of dietary fish oil supplementation, metformin, and fish oil in combination with metformin on fasting and non-fasting plasma TG, apoB48 and apoB100-lipoprotein concentrations.
- To determine the physiological mechanisms associated with the effect of dietary fish oil supplementation and metformin on in vivo plasma lipid and apoB-lipoprotein kinetics. We will quantitate the in vivo production and kinetics of plasma TG, apoB48 and apoB100-lipoproteins in plasma and isolated lipoprotein fractions, using established methods.
- To explore the effects of dietary fish oil supplementation, metformin and fish oil in combination with metformin, on plasma insulin and testosterone, and the association with changes in plasma lipids and apoB-lipoprotein metabolism.
- Being tested
- Metformin, Fish Oil and Metformin, Fish Oil
- Keywords
- Polycystic Ovary Syndrome, metabolic and cardiovascular diseases, diabetes, obesity
- Medical subject headings
- Polycystic Ovary Syndrome, Lipid Metabolism Disorders, Cardiovascular Diseases, Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Metformin Hydrochloride Oral Antihyperglycemic Agent.
Manufacturer's standard 500 mg. Submission Control No.:128147
Fish Oil and MetforminCombination product
Combo of 2 other arms
Fish OilDietary supplement
Also called Fish Oil; Fish Oil 1200 Mg; Omega-3
NPN: 80028808 Licence Holder: WN Pharmaceuticals Ltd Dosage Form: Capsule, soft Recommended Route of Administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| Fish Oil | Other | Fish oil capsules 1200mg 6 tablets/day 12 weeks Receives: Dietary Supplement: Fish Oil |
| Metformin | Other | Metformin tablets (500 mg) 2/day 12 weeks Receives: Drug: Metformin |
| Fish Oil and Metformin | Other | Combo of other 2 arms Receives: Combination Product: Fish Oil and Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Triglycerides and apoB-lipoprotein remnants in non-fasting and fasted state
reported as mean +/- SEM
Measured: At baseline and postintervention at 12 weeks
Secondary outcomes (2)
Plasma insulin and glucose
reported as mean +/- SEM
Measured: At baseline and postintervention at 12 weeks
Plasma hormones, testosterone, SHBG, Estrogen
reported as mean +/- SEM
Measured: At baseline and postintervention at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start30 Jun 2016
- Primary completion12 Nov 2020
- Study completion12 Nov 2020
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 Polycystic Ovary SyndromeStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Outcomes at 6 and 12 weeks will be compared to baseline values to determine the efficacy of interventions. Participants will act as their own control in each intervention
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Women and Children's Health Research Institute, Canada, Canadian Institutes of Health Research (CIHR), Alberta Diabetes Institute, Heart and Stroke Foundation of Canada
- Responsible party
- Sponsor
- Investigators
- Donna F Vine, PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116203
- Sponsor's protocol ID
- PRO00059201
- Acronym
- PCOS
- Status last verified
- Feb 2025
- First submitted
- 5 May 2018
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There will be no sharing with other researchers.
Publications
Vine 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.
PubMed 27997268
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Fish Oil Intervention in Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT04116203
- Acronym / sponsor ID
- PCOS / PRO00059201
- Keywords
- Polycystic Ovary Syndrome, metabolic and cardiovascular diseases, diabetes, obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Women and Children's Health Research Institute, Canada, Canadian Institutes of Health Research (CIHR), Alberta Diabetes Institute, Heart and Stroke Foundation of Canada
- Study start
- 30 Jun 2016 (actual)
- Primary completion
- 12 Nov 2020 (actual)
- Study completion
- 12 Nov 2020 (actual)
- First posted
- 4 Oct 2019 (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.
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.
Detailed description
Specific Objectives;
- To determine the effect of dietary fish oil supplementation, metformin, and fish oil in combination with metformin on fasting and non-fasting plasma TG, apoB48 and apoB100-lipoprotein concentrations.
- To determine the physiological mechanisms associated with the effect of dietary fish oil supplementation and metformin on in vivo plasma lipid and apoB-lipoprotein kinetics. We will quantitate the in vivo production and kinetics of plasma TG, apoB48 and apoB100-lipoproteins in plasma and isolated lipoprotein fractions, using established methods.
- To explore the effects of dietary fish oil supplementation, metformin and fish oil in combination with metformin, on plasma insulin and testosterone, and the association with changes in plasma lipids and apoB-lipoprotein metabolism.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Outcomes at 6 and 12 weeks will be compared to baseline values to determine the efficacy of interventions. Participants will act as their own control in each intervention
| Arm | Type | Receives |
|---|---|---|
| Fish Oil | Other | Dietary Supplement: Fish OilFish oil capsules 1200mg 6 tablets/day 12 weeks |
| Metformin | Other | Drug: MetforminMetformin tablets (500 mg) 2/day 12 weeks |
| Fish Oil and Metformin | Other | Combination Product: Fish Oil and MetforminCombo of other 2 arms |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| MetforminAlso: Metformin Hydrochloride Oral Antihyperglycemic Agent.Manufacturer's standard 500 mg. Submission Control No.:128147 | Drug | Metformin |
| Fish Oil and MetforminCombo of 2 other arms | Combination product | Fish Oil and Metformin |
| Fish OilAlso: Fish Oil; Fish Oil 1200 Mg; Omega-3NPN: 80028808 Licence Holder: WN Pharmaceuticals Ltd Dosage Form: Capsule, soft Recommended Route of Administration: Oral | Dietary supplement | Fish Oil |
Primary outcome
Plasma Triglycerides and apoB-lipoprotein remnants in non-fasting and fasted state
Time frame: At baseline and postintervention at 12 weeks
reported as mean +/- SEM
2 secondary outcomes
Plasma insulin and glucose
Time frame: At baseline and postintervention at 12 weeks
Plasma hormones, testosterone, SHBG, Estrogen
Time frame: At baseline and postintervention at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Results publication: PubMed 27997268Vine 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.
- Individual participant dataSharing planned: No. There will be no sharing with other researchers.
Related trials for Polycystic Ovary Syndrome
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Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
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The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
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The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
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Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
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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. This study is not recruiting at the moment.
Donna F Vine, PhD principal investigator
Associate Professor
2 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 Metformin, Fish Oil and Metformin and Fish Oil in people with Polycystic Ovary Syndrome and Lipid Metabolism Disorders, run by University of Alberta at 2 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Triglycerides and apoB-lipoprotein remnants in non-fasting and fasted state (time frame: At baseline and postintervention at 12 weeks). 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 NCT04116203, 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 28 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.