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
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 84
- Locations
- 1
Study Overview
Brief 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:
- Improve how well the body produces insulin and responds to it,
- 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.
Detailed Description
Background and Rationale:
According to the International Diabetes Federation, about 590 million adults worldwide-or 1 in 9 adults-were living with diabetes in 2025, most of whom had type 2 diabetes (T2D). An additional 230 million adults (about 4 in 10) are unaware that they have diabetes and therefore remain undiagnosed. Diabetes substantially increases the risk of illness and death and has an impact comparable to aging approximately 15 years, making it a leading cause of disability and mortality worldwide.
Type 2 diabetes develops gradually as multiple risk factors accumulate over time, including unhealthy lifestyle habits and aging. These factors reduce the body's ability to produce insulin and/or respond effectively to insulin, a hormone that regulates blood sugar levels. As a result, blood sugar levels progressively rise and may eventually lead to a diagnosis of T2D.
Importantly, type 2 diabetes is preventable.
In people with T2D, elevated blood levels of apolipoprotein B (apoB) increase the risk of cardiovascular disease (apoB is a measure of the number of particles that carry "bad" cholesterol known as low density lipoproteins (LDL)). Traditionally, high apoB levels were considered a consequence of T2D. However, research from the principal investigator's laboratory has shown that high apoB levels may also contribute to the development of T2D.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •Known history of difficulties accessing a vein
- •Known history of vagal shock or loss of consciousness during blood withdrawal
- •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); )
- •Allergy to seafood/fish or corn oil
- •Allergy to bovine gelatine or glycerine (softgel components)
- •Allergy to Xylocaine (anesthesia used during fat tissue biopsy)
- •Anticipated surgery or blood transfusion
- •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)
- •Other conditions deemed inappropriate by the study physician (e.g. difficulties in understanding/communicating in French or English)
Investigators
May Faraj, PDt, PhD
Professor
Institut de Recherches Cliniques de Montreal