Home/Loved One/NCT07575438
Phase 2Recruiting
View on ClinicalTrials.gov

Testing Fish Oil against a placebo for type 2 diabetes

Official title: Effects of Different Fish Oil Types on Type 2 Diabetes Risk Factors in High-Risk Adults

Role of EPA and DHA as Tailored Therapy for People Living With Obesity and High-risk for Type 2 Diabetes (END-T2D): a Randomized Controlled Trial

Condition: Type 2 DiabetesSponsor: May Faraj, PDt, PhDTarget enrollment: 84
  • Phase 2
  • 3 groups
  • One site, in Montreal
  • Recruiting
Institut de recherches cliniques de Montréal (IRCM), Montreal, Quebec

Interventions

  • Other intervention

    Fish Oil

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

  • Other intervention

    Fish Oil

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

  • Other intervention

    Corn oil control

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

Canadian Sites (1)

1 of 1 recruiting

  • Institut de recherches cliniques de Montréal (IRCM)

    Montreal, Quebec

    Recruiting

Eligibility Criteria

See who this study is looking for37 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +With a body mass index (BMI \>25-40 kg/m2)
  • +Males and post-menopausal females:
  • +Having confirmed menopausal status (FSH ≥ 30 U/l)
  • +Low-moderate alcohol consumption: \<7 alcoholic servings/ week
  • +Plasma apoB ≥1.05 g/L
  • +Non-smokers (tobacco) or have quitted for over a year

Exclusion

  • −Lack of time to participate in the full length of the study (18-22 weeks)
  • −Allergy to seafood/fish or corn oil
  • −Allergy to bovine gelatine or glycerine (softgel components)
  • −Allergy to Xylocaine (anesthesia used during fat tissue biopsy)
  • −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
  • −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); )
  • −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
  • −Other conditions deemed inappropriate by the study physician (e.g. difficulties in understanding/communicating in French or English)
  • −Anticipated surgery or blood transfusion
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a way to prevent a condition from developing.

Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 3 groups in this study.

Groups A and B, the comparison group, receive Fish Oil.

Registry label: A: Eicosapentaenoic acid (EPA) · B: Docosahexaenoic acid (DHA)

Group C, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Corn oil controlControl groupThe group a new treatment is measured against.Read more →.

Registry label: C: Corn oil

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.

One group receives an existing treatment, so the two can be compared.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists an age range of 40 years to 70 years.

The study is open to people of any sex.

The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 84 people.

The study is currently expected to finish around December 2029.

The main measurement is taken over: 12-weeks.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Change from baselineBaselineYour starting measurements, taken before treatment begins.Read more → to 12 weeks in the disposition index — measured over 12-weeks.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT07575438 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About Fish OilDietary supplement

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

From the trial registry — its own words, unedited.

What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.

Read the full explanation → · in clinical review

About Fish OilDietary supplement

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

From the trial registry — its own words, unedited.

What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.

Read the full explanation → · in clinical review

About Corn oil controlDietary supplement

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

From the trial registry — its own words, unedited.

What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: an age range of 40 years to 70 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.

One group receives an existing treatment so the two can be compared.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists an age range of 40 years to 70 years.

It is open to people of any sex.

It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: 12-weeks.

The study as a whole is currently expected to finish around 2029-12-31.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 84 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: Montreal, Quebec, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

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.

Worth passing on?

Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.

Review the Care Package

This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.