Effects of Different Fish Oil Types on Type 2 Diabetes Risk Factors in High-Risk Adults (NCT07575438) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Effects of Different Fish Oil Types on Type 2 Diabetes Risk Factors in High-Risk Adults
Canada84 participantsStarted 2026-07
Plain-language summary
The purpose of this clinical trial is to find out whether one type of fish oil works better than another at improving metabolic health in people who are at high risk of developing type 2 diabetes.
Some metabolic problems-such as difficulty controlling blood sugar, unhealthy particles that transport cholesterol in the blood, and poor fat tissue function-can increase the risk of type 2 diabetes. This study aims to determine whether different types of fish oil can:
1. Improve how well the body produces insulin and responds to it,
2. Improve the quality of the particles that carry "bad" cholesterol in the blood, and 3) Improve the health and function of participants' fat tissue.
To answer these questions, researchers will compare the effects of two types of fish oil: EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid). These will be compared with corn oil, which is used as a placebo and does not contain EPA or DHA.
When included in this study, participants will:
A) Take softgel capsules containing EPA, DHA, or placebo (corn oil) every day for 12 weeks, B) Keep a daily log to record when they take their study softgels, and C) Visit the research unit six times, including one and a half days before and after the intervention, to complete specialized metabolic tests that are mostly only available in research settings.
Who can participate
Age range
40 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Males and post-menopausal females:
* With a body mass index (BMI \>25-40 kg/m2)
* Having confirmed menopausal status (FSH ≥ 30 U/l)
* Non-smokers (tobacco) or have quitted for over a year
* Low-moderate alcohol consumption: \<7 alcoholic servings/ week
* Plasma apoB ≥1.05 g/L
Exclusion Criteria:
* Elevated risk of cardiovascular disease (≥ 20% of calculated Framingham Risk Score)
* Prior history of cardiovascular events (e.g. stroke, transient ischemic attack, myocardial infarction, angina, heart failure, arrhythmias, flutter, atrial …)
* Systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg
* Diabetes or HbA1c ≥ 6.5%
* Reactive hypoglycaemia
* Prior history of cancer within the last 3 years or if lymph nodes were removed
* Thyroid disease - untreated or unstable Synthroid dose
* Severe renal dysfunction - eGFR \< 30 mL/min/1.73 m²
* Hepatic dysfunction - AST/ALT \> 3 times normal limit
* Anemia - Hb \< 120 g/L in females and \< 130 in males
* Bleeding disorders
* Blood coagulation problems (i.e. bleeding predisposition)
* Malabsorptive disease or surgeries (e.g. bariatric surgeries)
* Autoimmune and chronic inflammatory disease (i.e. celiac, inflammatory bowel, Graves, multiple sclerosis, psoriasis, rheumatoid arthritis, and lupus).
* Chronic diarrhea
* Cholecystectomy (e.g. removal of gall bladder)
* Sleep apnea
* Seizures
* Known history of difficulties accessing a vein
* Known history of vagal shock or loss of consciousness dur…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline to 12 weeks in the disposition index