Using omega-3 fatty acids to target diabetes risk factors in people with normal cholesterol

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the relationship between low-density lipoprotein cholesterol (LDL-C) levels and the risk of developing type 2 diabetes (T2D) in individuals with normal cholesterol levels. It aims to understand how upregulating LDL receptors in white adipose tissue may activate inflammatory pathways that contribute to T2D risk. Participants will receive a 6-month supplementation of omega-3 fatty acids to assess its potential in mitigating these risks. The study will involve both clinical assessments and mechanistic research to explore the underlying biological mechanisms.

Why it matters

Who can join: the full rules

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

Where it's running

• Montreal Clinical Research Institute
  Montreal, Quebec, Canada Recruiting

Study contacts

• Principal investigator: May Faraj, PDt, PhD — Montreal Clinical Research Institute/ University of Montreal
• Study coordinator: Justine Fricher, MSc
• Email: justine.fricher@ircm.qc.ca
• Phone: 514-987-5500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.