Recruiting
Phase 2

EPA vs. DHA

Sponsor:

May Faraj, PDt, PhD

Code:

NCT07575438

Conditions

Type 2 Diabetes

Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)

Prediabetes / Type 2 Diabetes

Obesity & Overweight

Obesity and Diabetes Mellitus, Type 2

Eligibility Criteria

Sex: All

Age: 40 - 70

Healthy Volunteers: Accepted

Interventions

Fish Oil

Fish Oil

Corn oil control

Study Details

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:

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.

Conditions

Type 2 Diabetes

Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)

Prediabetes / Type 2 Diabetes

Obesity & Overweight

Obesity and Diabetes Mellitus, Type 2

Study ID

NCT07575438

Start date

Oct 5, 2026

Status verified date

Oct, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70

Healthy Volunteers: Accepted

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 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)

Study Design

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Eicosapentaenoic acid (EPA)

4 g EPA per day

active comparator: Docosahexaenoic acid (DHA)

4 g DHA per day

placebo comparator: Corn oil

0 g EPA and DHA per day

Interventions

Fish Oil

Four softgels of Carlson Elite EPA Gems taken orally per day (NPN 80079735, 1 g EPA/softgel)

Fish Oil

Four softgels of Carlson Elite DHA Gems taken orally per day (NPN 80079736, 1 g DHA/softgel)

Corn oil control

Four softgels of Carlson placebo taken orally per day (food-grade corn oil, 0 g EPA and DHA per softgel)

Primary outcome measure

  • Change from baseline to 12 weeks in the disposition index [ Time Frame: 12-weeks ]

Central Contacts and Locations

Central contacts

Justine Fricher, M.Sc.

514-987-5500t2dresearch@ircm.qc.ca

Clinical coordinator and nurse

514-987-5655t2dresearch@ircm.qc.ca

Locations

Institut de recherches cliniques de Montréal (IRCM)

Recruiting

Montreal, Quebec, Canada, H2W 1R7

Contacts

May Faraj, P.Dt., Ph.D.

T2Dresearch@ircm.qc.ca

Principal Investigator:

May Faraj, P.Dt., Ph.D.

More Information

Sponsor

May Faraj, PDt, PhD

Last update posted

Oct 8, 2026

Last verified

Oct, 2026

Keywords

  • Omega-3 fatty acids
  • EPA
  • DHA
  • Low-density lipoproteins
  • LDL
  • Overweight
  • Obesity
  • Insulin secretion
  • Insulin sensitivity
  • LDL size
  • LDL diameter
  • Inflammation
  • White adipose tissue
  • HyperapoB
  • Prediabetes
  • Botnia clamp
  • Intravenous glucose tolerance test
  • Hyperinsulinemic euglycemic clamp
  • Adipose tissue needle biopsy
  • Oral glucose tolerance test
  • Eicosapentaenoic acid
  • Docosahexaenoic acid
  • High plasma apoB
  • Disposition index

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by May Faraj, PDt, PhD on 2026-10-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.