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Omega-3 Fatty Acids

Omega-3 Fatty Acids for Type 2 Diabetes Risk Factors

N/A
Recruiting
Led By May Faraj, PDt, PhD
Research Sponsored by Institut de Recherches Cliniques de Montreal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men and post-menopausal women with a body mass index (BMI) of 25-40 kg/m2
Aged between 45 and 74 years
Must not have
Type 1 or 2 diabetes or fasting glucose > 7.0 mmol/L
Blood coagulation problems (i.e. bleeding predisposition)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 24 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is looking at whether lowering LDL cholesterol increases the risk for type 2 diabetes, and whether omega-3 fatty acids can help treat the same defects that are caused by LDL entry into fat tissue.

Who is the study for?
This trial is for sedentary adults aged 45-74 with a BMI of 25-40 who are non-smokers, drink little alcohol, and have normal blood LDL cholesterol. It's not for those allergic to seafood or fish, with recent cancer history, high cardiovascular risk needing immediate treatment, diabetes, severe hypertension, renal or liver dysfunction, certain medication use or other medical conditions that the physician finds unsuitable.
What is being tested?
The study tests if omega-3 fatty acids from fish oil can reduce the risk of type 2 diabetes in people with higher LDL receptors and fat tissue entry. Participants will take omega-3 supplements for six months to see if it treats defects caused by LDL entering fat tissue.
What are the potential side effects?
While not explicitly stated in the provided information, common side effects of taking omega-3 supplements may include a fishy aftertaste, upset stomach, loose stools and nausea. More serious side effects are rare but could involve increased bleeding tendency.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a man or post-menopausal woman with a BMI between 25-40.
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I am between 45 and 74 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have diabetes or my fasting blood sugar is high.
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I have a condition that makes me bleed easily.
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I have had a heart attack, stroke, or other serious heart problems.
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I have seizures.
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I cannot eat high-fat foods like croissants, cheese, bacon, or brownies.
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My thyroid condition is either untreated or not under control.
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My kidney function is impaired or my creatinine level is high.
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I have a high risk of heart disease needing treatment to lower my cholesterol.
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I have an autoimmune or chronic inflammatory condition like lupus or rheumatoid arthritis.
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I have had cancer in the past 3 years.
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My liver enzymes are more than three times the normal limit.
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I take more than 250 mg of omega-3 supplements daily.
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I have been diagnosed with sleep apnea.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Fasting white adipose tissue NLRP3 inflammasome activation
Secondary study objectives
Body composition
Disposition index
Energy intake
+8 more

Side effects data

From 2017 Phase 4 trial • 413 Patients • NCT02642159
5%
Diarrhoea
5%
Urinary tract infection
2%
Bronchitis
2%
Arthralgia
1%
Angina unstable
1%
Pneumonia
1%
Non-cardiac chest pain
1%
Ischaemic stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
Usual Care

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Omega-3 fatty acidsExperimental Treatment1 Intervention
3.6 g EPA:DHA / day (2:1)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omega-3 fatty acids
2018
Completed Phase 4
~2640

Find a Location

Who is running the clinical trial?

Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,388 Previous Clinical Trials
26,518,025 Total Patients Enrolled
Institut de Recherches Cliniques de MontrealLead Sponsor
71 Previous Clinical Trials
10,352 Total Patients Enrolled
May Faraj, PDt, PhDPrincipal InvestigatorMontreal Clinical Research Institute/ University of Montreal
1 Previous Clinical Trials
41 Total Patients Enrolled

Media Library

Omega-3 fatty acids (Omega-3 Fatty Acids) Clinical Trial Eligibility Overview. Trial Name: NCT04485871 — N/A
Type 2 Diabetes Research Study Groups: Omega-3 fatty acids
Type 2 Diabetes Clinical Trial 2023: Omega-3 fatty acids Highlights & Side Effects. Trial Name: NCT04485871 — N/A
Omega-3 fatty acids (Omega-3 Fatty Acids) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04485871 — N/A
~8 spots leftby Oct 2025
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