Fish oil may counteract hidden diabetes risk from low bad cholesterol
NCT ID NCT04485871
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at why having low 'bad' cholesterol (LDL) might actually increase the risk of type 2 diabetes. Researchers think LDL entering fat tissue may cause problems that lead to diabetes. They will test if taking omega-3 fish oil supplements for 6 months can reduce that risk in 48 adults aged 45-74 with normal LDL levels.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2019
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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45 to 74 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Montreal Clinical Research Institute
RECRUITINGMontreal, Quebec, H2W 1R7, Canada
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