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

NCT07575438 | Not Yet Recruiting Phase 2

• 2 other identifiers: 2026-1363Award ID: EDA-25-1514974
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Improve how well the body produces insulin and responds to it,
2. 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.

Conditions

Type 2 Diabetes; Prediabetes (Insulin Resistance, Impaired Glucose Tolerance); Prediabetes / Type 2 Diabetes; Obesity & Overweight; Obesity and Diabetes Mellitus, Type 2

Keywords

Omega-3 fatty acids; EPA; DHA; Low-density lipoproteins; LDL; Overweight; Obesity; Insulin secretion; Insulin sensitivity; LDL size; LDL diameter; Inflammation; White adipose tissue; HyperapoB; Prediabetes; Botnia clamp; Intravenous glucose tolerance test; Hyperinsulinemic euglycemic clamp; Adipose tissue needle biopsy; Oral glucose tolerance test; Eicosapentaenoic acid; Docosahexaenoic acid; High plasma apoB; Disposition index

Outcome Measures

Primary Outcomes (1)

• Change from baseline to 12 weeks in the disposition index

  Disposition index calculated as first phase glucose-induced insulin secretion multiplied by insulin sensitivity measured during the Botnia clamp \[(ng C-peptide/mL)\*(mg dextrose/kg/min)/(µU insulin/mL)\]

  12-weeks

Secondary Outcomes (5)

• Change from baseline to 12 weeks in glucose-induced insulin secretion

  12 weeks

• Change from baseline to 12 weeks in insulin sensitivity

  12 weeks

• Change from baseline to 12 weeks in the oral disposition index

  12 week

• Change from baseline to 12 weeks in low-density lipoprotein (LDL) size

  12 weeks

• Change from baseline to 12 weeks in LDL-induced white adipose tissue (WAT) inflammation

  12 weeks

Other Outcomes (1)

• Change from baseline to 12 weeks in LDL-induced WAT inflammation

  12 weeks

Study Arms (3)

Eicosapentaenoic acid (EPA)

ACTIVE COMPARATOR

Four softgels of Carlson Elite EPA Gems (NPN 80079735) providing 4 g EPA per day

Dietary Supplement: Fish Oil

Docosahexaenoic acid (DHA)

ACTIVE COMPARATOR

Four softgels of Carlson Elite DHA Gems (NPN 80079736) providing 4 g DHA per day

Dietary Supplement: Fish Oil

Corn oil

PLACEBO COMPARATOR

Four softgels of Carlson placebo softgels providing 0 g EPA and DHA per day

Dietary Supplement: Fish Oil

Interventions

Fish Oil DIETARY_SUPPLEMENT

Fish oil concentrate with EPA, fish oil concentrate with DHA, versus corn oil (placebo) on risk factors for type 2 diabetes

Corn oil; Docosahexaenoic acid (DHA); Eicosapentaenoic acid (EPA)

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• May Faraj, PDt, PhD: lead
• Diabetes Canada: collaborator

Study Sites (1)

Institut de recherches cliniques de Montréal (IRCM)

Montreal, Quebec, H2W 1R7, Canada

Location

Related Publications (6)

• Faraj M, Messier L, Bastard JP, Tardif A, Godbout A, Prud'homme D, Rabasa-Lhoret R. Apolipoprotein B: a predictor of inflammatory status in postmenopausal overweight and obese women. Diabetologia. 2006 Jul;49(7):1637-46. doi: 10.1007/s00125-006-0259-7. Epub 2006 May 3.

  PMID: 16752182 BACKGROUND

• Onat A, Can G, Hergenc G, Yazici M, Karabulut A, Albayrak S. Serum apolipoprotein B predicts dyslipidemia, metabolic syndrome and, in women, hypertension and diabetes, independent of markers of central obesity and inflammation. Int J Obes (Lond). 2007 Jul;31(7):1119-25. doi: 10.1038/sj.ijo.0803552. Epub 2007 Feb 13.

  PMID: 17299378 BACKGROUND

• Pencina KM, Pencina MJ, Dufresne L, Holmes M, Thanassoulis G, Sniderman AD. An adverse lipoprotein phenotype-hypertriglyceridaemic hyperapolipoprotein B-and the long-term risk of type 2 diabetes: a prospective, longitudinal, observational cohort study. Lancet Healthy Longev. 2022 May;3(5):e339-e346. doi: 10.1016/S2666-7568(22)00079-4. Epub 2022 May 4.

  PMID: 36098309 BACKGROUND

• Richardson TG, Wang Q, Sanderson E, Mahajan A, McCarthy MI, Frayling TM, Ala-Korpela M, Sniderman A, Smith GD, Holmes MV. Effects of apolipoprotein B on lifespan and risks of major diseases including type 2 diabetes: a mendelian randomisation analysis using outcomes in first-degree relatives. Lancet Healthy Longev. 2021 Jun;2(6):e317-e326. doi: 10.1016/S2666-7568(21)00086-6. Epub 2021 May 21.

  PMID: 34729547 BACKGROUND

• Lamantia V, Bissonnette S, Beaudry M, Cyr Y, Rosiers CD, Baass A, Faraj M. EPA and DHA inhibit LDL-induced upregulation of human adipose tissue NLRP3 inflammasome/IL-1beta pathway and its association with diabetes risk factors. Sci Rep. 2024 Nov 7;14(1):27146. doi: 10.1038/s41598-024-73672-6.

  PMID: 39511203 BACKGROUND

• Bissonnette S, Lamantia V, Ouimet B, Cyr Y, Devaux M, Rabasa-Lhoret R, Chretien M, Saleh M, Faraj M. Native low-density lipoproteins are priming signals of the NLRP3 inflammasome/interleukin-1beta pathway in human adipose tissue and macrophages. Sci Rep. 2023 Nov 1;13(1):18848. doi: 10.1038/s41598-023-45870-1.

  PMID: 37914804 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Prediabetic State; Insulin Resistance; Glucose Intolerance; Obesity; Overweight; Diabetes Mellitus; Inflammation

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Hyperglycemia; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Officials

• May Faraj, P.Dt., Ph.D.

  Institut de recherches cliniques de Montréal (IRCM)/ Université de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justine Fricher, M.Sc.

CONTACT

514-987-5500; t2dresearch@ircm.qc.ca

Clinical coordinator and nurse

CONTACT

514-987-5655; t2dresearch@ircm.qc.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Three-arm placebo-controlled randomized trial

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 8, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)