Comparing two fish oils with corn oil in adults at high risk of diabetes
Tests EPA and DHA fish oils against corn oil in adults with obesity.
Plain-language title generated from the registry record
Registry title: Effects of Different Fish Oil Types on Type 2 Diabetes Risk Factors in High-Risk Adults
Key facts
- Where
- Montreal, CanadaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men and post-menopausal women with overweight or obesity and a high blood apoB level, who are at high risk of type 2 diabetes but do not have diabetes. They take EPA, DHA or placebo capsules for 12 weeks.
- Age
- 40 to 70 years
- Sex
- Men and post-menopausal women (menopause confirmed by blood test, FSH ≥ 30 U/l)
- Disease stage
- Body mass index (BMI) above 25 and up to 40 kg/m2. No diabetes (HbA1c below 6.5% (48 mmol/mol)).
- Earlier treatment
- Cannot be taking more than 1 gm of EPA and/or DHA supplements per day. Cannot be taking weight-loss medication, cholesterol-lowering medication, blood thinners or blood pressure medication.
- Biomarker or test result
- Plasma apoB of 1.05 g/L or more.
Main reasons for not taking part
- Diabetes or HbA1c of 6.5% (48 mmol/mol) or more
- Earlier heart or blood vessel event such as stroke or heart attack, or a high heart risk score (20% or more)
- Smoking within the last year, or 7 or more alcoholic drinks per week
- Allergy to fish, seafood, corn oil, bovine gelatine or glycerine
- Severe kidney problems or liver problems
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 70 years old?
Source: NCT07575438, who can take part
Where in Canada
- Institut de Recherches Cliniques de Montréal (IRCM)Montreal, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- May Faraj, PDt, PhD
- Trial code
- NCT07575438
- Record updated
- 8 October 2026
- Original description
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.Read full original descriptionShow less
Role of EPA and DHA as Tailored Therapy for People Living With Obesity and High-risk for Type 2 Diabetes (END-T2D): a Randomized Controlled Trial
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.
Inclusion: 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: Prior history of cardiovascular events (e.g. stroke, transient ischemic attack, myocardial infarction, angina, heart failure, arrhythmias, flutter, atrial …); Concomitant medications (systemic corticosteroids; hypertension medication; anti-psychotic medications - psycho-active medication that promote weight gain; anticoagulant or anti-aggregates treatment (e.g. aspirin, NSAIDs, warfarin, coumadin..); systemic adrenergic agonists; weight-loss medication (e.g. GLP-1 agonists); lipid lowering medication (e.g. statins, anti-PCSK9); ); Anticipated surgery or blood transfusion; Elevated risk of cardiovascular disease (≥ 20% of calculated Framingham Risk Score); Prior history of cancer within the last 3 years or if lymph nodes were removed; Thyroid disease - untreated or unstable Synthroid dose; 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); Seizures; Known history of difficulties accessing a vein; Known history of vagal shock or loss of consciousness during blood withdrawal; Allergy to seafood/fish or corn oil; Allergy to bovine gelatine or glycerine (softgel components); Allergy to Xylocaine (anesthesia used during fat tissue biopsy); Other conditions deemed inappropriate by the study physician (e.g. difficulties in understanding/communicating in French or English); Diabetes or HbA1c ≥ 6.5%; 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; Systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg; Reactive hypoglycaemia; Chronic diarrhea; Cholecystectomy (e.g. removal of gall bladder); Sleep apnea; Known substance abuse; Very high physical activity (> 5 hours of aerobic exercise per week); Already taking more than 1 gm of EPA and/or DHA supplementation per day; Lack of compliance to the study requirements (i.e. not being fasting); Cancellation of the same scheduled testing visit more than once; Lack of time to participate in the full length of the study (18-22 weeks).