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Fish oil may counteract hidden diabetes risk from low bad cholesterol

NCT ID NCT04485871

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 48 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2019

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

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

45 to 74 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Montreal Clinical Research Institute

    RECRUITING

    Montreal, Quebec, H2W 1R7, Canada

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