Recruiting

Omega-3

Sponsor:

Institut de Recherches Cliniques de Montreal

Code:

NCT04485871

Conditions

Type 2 Diabetes

Inflammation

Insulin Sensitivity/Resistance

Fatty Acids, Omega-3

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

Interventions

Omega-3 fatty acids

Study Details

Brief summary:

Every 3 minutes a new case of diabetes is diagnosed in Canada, mostly type 2 diabetes (T2D) increasing the risk for heart disease. T2D and heart disease share many common risk factors such as aging, obesity and unhealthy lifestyle.

Paradoxically however, while lowering blood LDL, commonly known as "bad cholesterol", is protective against heart disease, research over the past 10 years have shown that the lower is blood LDL, the higher is the chance of developing T2D. This phenomena is happening whether blood LDL is lowered by a common drug against heart disease called Statins, or by being born with certain variations in genes, some of which are very common (\~80% of people have them).

To date, it is unclear why lowering blood LDL is associated with higher risk for diabetes, and whether this can be treated naturally with certain nutrients.

Investigators believe that lowering blood LDL by forcing LDL entry into the body tissue through their receptors promotes T2D. This is because investigators have shown that LDL entry into human fat tissue induces fat tissue dysfunction, which would promote T2D especially in subjects with excess weight.

On the other hand, investigators have shown that omega-3 fatty acids (omega-3) can directly treat the same defects induced by LDL entry into fat tissue. Omega-3 is a unique type of fat that is found mostly in fish oil.

Thus the objectives of this clinical trial to be conducted in 48 subjects with normal blood LDL are to explore if:

1. Subjects with higher LDL receptors and LDL entry into fat tissue have higher risk factors for T2D compared to subjects with lower LDL receptors and LDL entry into fat tissue
2. 6-month supplementation of omega-3 from fish oil can treat subjects with higher LDL receptors and LDL entry into fat tissue reducing their risk for T2D.

This study will thus explore and attempt to treat a new risk factor for T2D using an inexpensive and widely accessible nutraceutical, which would aid in preventing T2D in humans.

Conditions

Type 2 Diabetes

Inflammation

Insulin Sensitivity/Resistance

Fatty Acids, Omega-3

Study ID

NCT04485871

Start date

Dec 19, 2019

Status verified date

Mar, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

Men and post-menopausal women:

  • Having a body mass index (BMI= 25-40 kg/m2)
  • Aged between 45 and 74 years
  • Having confirmed menopausal status (FSH ≥ 30 U/l)
  • Non-smoker
  • Sedentary (less than 2 hours of structured physical exercise (ex: sports club) per week)
  • Low alcohol consumption: less than 2 alcoholic drinks/day

Exclusion Criteria:

  • Plasma LDL cholesterol > 3.5 mmol/L (i.e. > 75th percentile in a Canadian population).
  • Elevated risk of cardiovascular disease (≥ 20% of calculated Framingham Risk Score) who would require immediate medical intervention by lipid-lowering agents.
  • Prior history of cardiovascular events (like stroke, transient ischemic attack, myocardial infarction, angina, heart failure…)
  • Systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg
  • Type 1 or 2 diabetes or fasting glucose > 7.0 mmol/L
  • Prior history of cancer within the last 3 years
  • Thyroid disease - untreated or unstable
  • Anemia - Hb < 120 g/L
  • Renal dysfunction or plasma creatinine > 100 µmol/L
  • Hepatic dysfunction - AST/ALT > 3 times normal limit
  • Blood coagulation problems (i.e. bleeding predisposition)
  • Autoimmune and chronic inflammatory disease (i.e. celiac, inflammatory bowel, Graves, multiple sclerosis, psoriasis, rheumatoid arthritis, and lupus).Known history of difficulties accessing a vein
  • Claustrophobia
  • Sleep apnea
  • Seizures
  • Concomitant medications: Hormone replacement therapy (except thyroid hormone at a stable dose), systemic corticosteroids, anti-psychotic medications and psycho-active medication, anticoagulant or anti-aggregates treatment (Aspirin, NSAIDs, warfarin, coumadin..), adrenergic agonist, anti-hypertensive drugs, weight-loss medication, lipid lowering medication
  • Known substance abuse
  • Already taking more than 250 mg of omega-3 supplements (EPA/DHA) per day
  • Allergy to seafood or fish
  • Allergy to Xylocaine
  • Unable to eat the components of the high fat meal (croissant, cheese, bacon, brownies)
  • None compliance to the study requirements (i.e. not being fasting) or cancellation of the same scheduled testing visit more than once.
  • Lack of time to participate in the full length of the study (33 weeks)
  • Have exceeded the annual total allowed radiation dose (like X-ray scans and/or tomography in the previous year or in the year to come) according to the physician's judgement.
  • All other medical or psychological conditions deemed inappropriate according to the physician

Study Design

Enrollment

48 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Omega-3 fatty acids

3.6 g EPA:DHA / day (2:1)

Interventions

Omega-3 fatty acids

Triple Strength Omega-3 from Webber Naturals; 4 oral softgels (600 mg EPA and 300 mg DHA / softgel)

Primary outcome measure

  • Fasting white adipose tissue NLRP3 inflammasome activation [ Time Frame: Baseline ]
  • Fasting white adipose tissue NLRP3 inflammasome activation [ Time Frame: At 24 weeks ]

Central Contacts and Locations

Central contacts

Justine Fricher, MSc

514-987-5500justine.fricher@ircm.qc.ca

Rianne Mahiout, BSc

514-987-5500rianne.mahiout@ircm.qc.ca

Locations

Montreal Clinical Research Institute

Recruiting

Montreal, Quebec, Canada, H2W 1R7

Contacts

Justine Fricher, MSc

514-987-5500justine.fricher@ircm.qc.ca

Principal Investigator:

May Faraj, PDt, PhD

More Information

Sponsor

Institut de Recherches Cliniques de Montreal

Last update posted

Mar 12, 2026

Last verified

Mar, 2026

Keywords

  • Proprotein Convertase Subtilisin / kexin Type 9 (PCSK9)
  • NLRP3 inflammasome
  • Eicosapentaenoic acid (EPA)
  • Docosahexaenoic acid (DHA)
  • White adipose tissue
  • Fat metabolism
  • ApoB-lipoproteins
  • LDL receptors (LDLR)
  • Cluster of differentiation 36 (CD36)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Institut de Recherches Cliniques de Montreal on 2026-03-12.