Omega-3 Fatty Acids for Type 2 Diabetes Risk Factors

Recruiting at 1 trial location

Overseen By Rianne Mahiout, BSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Institut de Recherches Cliniques de Montreal

Must not be taking: Hormone therapy, Corticosteroids, Antipsychotics, others

Disqualifiers: Cardiovascular disease, Diabetes, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 24 weeks

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether omega-3 fatty acids from fish oil can reduce the risk of developing type 2 diabetes (T2D) by addressing fat tissue issues related to LDL ("bad cholesterol") entry. Researchers focus on whether individuals with higher LDL receptor activity in their fat tissue face an increased risk for T2D. The trial includes a 6-month omega-3 supplementation to assess its potential benefits. It is suitable for men and post-menopausal women with a body mass index indicating excess weight, who are mostly inactive, have low alcohol intake, and are non-smokers. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new preventive strategies for T2D.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications. The trial excludes participants on hormone replacement therapy (except stable thyroid hormone), systemic corticosteroids, anti-psychotic medications, psycho-active medication, anticoagulant or anti-aggregates treatment, adrenergic agonist, anti-hypertensive drugs, weight-loss medication, and lipid-lowering medication.

What prior data suggests that omega-3 fatty acids are safe for humans?

Research has shown that omega-3 fatty acids are usually safe for consumption. These fats, often found in fish oil, benefit heart health and can help control blood sugar levels. Some individuals use them to ease pain and swelling, and they can also prevent blood from clotting too easily.

Side effects are generally minor and might include an upset stomach or a fishy aftertaste, though these are uncommon and usually mild. Omega-3 fatty acids are a natural part of many diets, and many people take them as supplements without serious problems.

Overall, omega-3 fatty acids are considered safe for most people and have been shown to help with health issues related to type 2 diabetes and heart disease risk factors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for type 2 diabetes, such as metformin and insulin, Omega-3 fatty acids offer a different approach by targeting inflammation and lipid levels. These fatty acids, specifically EPA and DHA, are derived from fish oil and have anti-inflammatory properties that could address underlying issues in diabetes rather than just managing blood sugar levels. Researchers are excited because Omega-3s could potentially improve heart health and reduce risk factors associated with diabetes, offering a more holistic benefit.

What evidence suggests that omega-3 fatty acids might be an effective treatment for type 2 diabetes risk factors?

Research has shown that omega-3 fatty acids benefit health, particularly for individuals with type 2 diabetes (T2D). Studies have found that omega-3s help manage blood sugar levels and improve blood fat balance. They are also associated with a lower risk of heart diseases in people with diabetes. Omega-3s may address issues in fat tissue caused by LDL, or "bad cholesterol," potentially reducing the risk of developing T2D. Overall, omega-3 supplements appear promising as a natural method to reduce T2D risk factors. Participants in this trial will receive omega-3 fatty acids to further investigate these potential benefits. ^{1 3 5 6 7}

Who Is on the Research Team?

May Faraj, PDt, PhD

Principal Investigator

Montreal Clinical Research Institute/ University of Montreal

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You do not exercise regularly (less than 2 hours of structured physical activity per week).

I am a man or post-menopausal woman with a BMI between 25-40.

You are confirmed to have reached menopause based on a hormone test result.

Exclusion Criteria

You are allergic to seafood or fish.

I have diabetes or my fasting blood sugar is high.

I have a condition that makes me bleed easily.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Weight Stabilization

Participants undergo weight stabilization with a +/- 2 kg change over 4 weeks and confirmation of eligibility after a medical examination

4 weeks

1 visit (in-person)

Baseline Testing

Baseline testing to assess participants' risk factors for T2D, including white adipose tissue NLRP3 inflammasome activity, systemic inflammation, and insulin secretion and sensitivity

1-4 weeks

2 visits (in-person)

Treatment

24-week intervention with omega-3 fatty acid supplementation (3.6 g EPA and DHA, 2:1 ratio)

24 weeks

Regular check-ins (frequency not specified)

Post Intervention Testing

Post intervention testing to assess risk factors for T2D that were measured at baseline

1-4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Omega-3 fatty acids

Trial Overview 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.

How Is the Trial Designed?

Group I: Omega-3 fatty acids Experimental Treatment 1 Intervention

3.6 g EPA:DHA / day (2:1)

Omega-3 fatty acids is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Omega-3 fatty acids for:

• Hypertriglyceridemia
• Cardiovascular health

Approved in European Union as Omega-3 fatty acids for:

• Hypertriglyceridemia
• Cardiovascular health

Approved in Canada as Omega-3 fatty acids for:

• Hypertriglyceridemia
• Cardiovascular health

Who Is Running the Clinical Trial?

Institut de Recherches Cliniques de Montreal

Lead Sponsor

Trials

72

Recruited

10,300+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

Polyunsaturated fatty acids (PUFA) of the n-3 series are crucial for health, offering benefits like reducing cardiovascular risk and improving insulin sensitivity, which can help protect against obesity and type 2 diabetes.

Despite their benefits, there is some controversy regarding the effects of n-3 versus n-6 fatty acids, and high doses of n-3 fatty acid supplements may have adverse effects, highlighting the need for careful dietary management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

N-3 fatty acids in glucose metabolism and insulin sensitivity. Martín de Santa Olalla, L., Sánchez Muniz, FJ., Vaquero, MP.[2022]

In a randomized, double-blind trial with 47 participants, krill oil supplementation for 4 weeks improved endothelial function and reduced blood C peptide levels and insulin resistance compared to olive oil.

After an additional 17 weeks of krill oil supplementation, participants showed significant improvements in endothelial function and increased levels of high-density lipoprotein (HDL), indicating potential cardiovascular benefits for individuals with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of krill oil on endothelial function and other cardiovascular risk factors in participants with type 2 diabetes, a randomized controlled trial. Lobraico, JM., DiLello, LC., Butler, AD., et al.[2019]

A systematic review of 46 randomized clinical trials involving 4991 patients with type 2 diabetes found that omega-3 polyunsaturated fatty acids (n-3 PUFAs) significantly improved several cardiovascular risk factors, including total cholesterol, triglycerides, and hemoglobin A1c levels.

The study indicates that while n-3 PUFAs positively affect cardiovascular risk markers, they do not significantly impact renal function or insulin resistance, suggesting a targeted benefit for lipid profiles in type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of omega-3 fatty acids in type 2 diabetes: A systematic review and meta-analysis. Xiao, Y., Zhang, Q., Liao, X., et al.[2022]

In a study of 2,212 middle-aged and older Finnish men, higher levels of serum long-chain omega-3 polyunsaturated fatty acids (PUFAs) like EPA, DPA, and DHA were linked to a 33% lower risk of developing type 2 diabetes over an average follow-up of 19.3 years.

No significant associations were found between type 2 diabetes risk and other factors such as dietary ALA, dietary fish intake, or hair mercury levels, suggesting that the protective effect is specifically related to serum long-chain omega-3 PUFAs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serum omega-3 polyunsaturated fatty acids and risk of incident type 2 diabetes in men: the Kuopio Ischemic Heart Disease Risk Factor study. Virtanen, JK., Mursu, J., Voutilainen, S., et al.[2018]

In a study with male C57BL/6N mice fed a high-fat diet, omega-3 phospholipids (ω3PL) preserved insulin sensitivity and improved glucose metabolism, unlike omega-3 triacylglycerols (ω3TG), which worsened insulin sensitivity.

The research suggests that omega-3 PUFA from phospholipids, particularly from Krill oil, may enhance glucose homeostasis and could be beneficial as nutritional supplements for improving insulin sensitivity in obese type 2 diabetics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased plasma levels of palmitoleic acid may contribute to beneficial effects of Krill oil on glucose homeostasis in dietary obese mice. Rossmeisl, M., Pavlisova, J., Bardova, K., et al.[2020]

In a study of 43,176 Chinese men and women aged 45-74, higher intakes of total omega-3 fatty acids were linked to a lower risk of developing type 2 diabetes, suggesting a protective effect.

Specifically, nonmarine omega-3 fatty acids (like ALA) were associated with a significant reduction in diabetes risk, while marine omega-3s (EPA and DHA) did not show a similar association.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omega-3 fatty acids and incident type 2 diabetes: the Singapore Chinese Health Study. Brostow, DP., Odegaard, AO., Koh, WP., et al.[2023]

A systematic review of 16 studies involving over 540,000 individuals found no significant association between the consumption of fish or seafood and the risk of developing type 2 diabetes, nor between EPA and DHA intake and diabetes risk.

While dietary alpha-linolenic acid (ALA) showed a non-significant trend towards a lower risk of diabetes, the overall findings suggest that neither fish/seafood nor EPA/DHA consumption poses major benefits or harms regarding diabetes development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omega-3 fatty acids and incident type 2 diabetes: a systematic review and meta-analysis. Wu, JH., Micha, R., Imamura, F., et al.[2022]

In a pooled analysis of 65,147 participants from 20 studies, higher levels of seafood-derived n-3 fatty acids (EPA, DPA, DHA) were linked to a significantly lower risk of developing type 2 diabetes (T2D), with hazard ratios indicating a protective effect.

In contrast, the plant-derived n-3 fatty acid ALA showed no significant association with T2D risk, suggesting that the source of n-3 fatty acids may influence their impact on diabetes prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

n-3 Fatty Acid Biomarkers and Incident Type 2 Diabetes: An Individual Participant-Level Pooling Project of 20 Prospective Cohort Studies. Qian, F., Ardisson Korat, AV., Imamura, F., et al.[2022]

A review of 11 clinical trials involving (n-3) fatty acids in participants with type 2 diabetes showed no significant changes in fasting glucose or insulin levels, indicating that these fatty acids may not directly improve blood sugar control.

However, (n-3) fatty acids were found to lower serum triglycerides and potentially improve arterial blood flow, suggesting they could have cardiovascular benefits for individuals with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

(n-3) Fatty Acids: Clinical Trials in People with Type 2 Diabetes. Hendrich, S.[2023]

Citations

1. ods.od.nih.gov ods.od.nih.gov/factsheets/Omega3FattyAcids-HealthProfessional/

Omega-3 Fatty Acids - Health Professional Fact Sheet Omega 3 fatty acids overview for health professionals. Research health effects, dosing, sources, deficiency, side effects, and interactions here.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0952327822000680

The effects of omega-3 fatty acids in type 2 diabetes The results of this systematic review suggest that n-3 PUFAs can improve cardiovascular risk factors in type 2 diabetes.

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa1804989

Effects of n−3 Fatty Acid Supplements in Diabetes Mellitus Increased intake of n−3 fatty acids has been associated with a reduced risk of cardiovascular disease in observational studies, ...

4. link.springer.com link.springer.com/article/10.1007/s13668-024-00561-9

Omega-3 Fatty Acids in Diabetes Mellitus Management Omega-3 polyunsaturated fatty acids are recognized for their advantageous impact on health. They assist in controlling blood sugar levels and lipid profile.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10334152/

Omega-3 Fatty Acids & Cardiovascular Outcomes in Diabetes Meta-analysis showed that ω-3 fatty acid supplementation reduces cardiovascular disease (CVD) risk in patients with diabetes (rate ration [RR] = 0.93; 95% ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK564314/

Omega-3 Fatty Acids - StatPearls - NCBI Bookshelf Omega-3 (ω-3) fatty acids, renowned for their multiple health benefits, are pivotal in managing hyperlipidemia by modulating lipid profiles.

7. webmd.com webmd.com/vitamins/ai/ingredientmono-1172/krill-oil

Krill Oil - Uses, Side Effects, and More Omega-3 fatty acids can reduce pain and swelling and also prevent the blood from clotting easily. People use krill oil for dry eye. It is also used for high ...