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

A vizsgálat adatai

Ki végzi

May Faraj, PDt, PhD

Azonosító

NCT07575438

A regiszteradat frissítve

2026. október 8.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

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

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.

Bevonási feltételek: 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.

Kizáró feltételek: Prior history of cardiovascular events (e.g. stroke, transient ischemic attack, myocardial infarction, angina, heart failure, arrhythmias, flutter, atrial …); 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); ); Anticipated surgery or blood transfusion; Elevated risk of cardiovascular disease (≥ 20% of calculated Framingham Risk Score); Prior history of cancer within the last 3 years or if lymph nodes were removed; Thyroid disease - untreated or unstable Synthroid dose; 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); Seizures; Known history of difficulties accessing a vein; Known history of vagal shock or loss of consciousness during blood withdrawal; Allergy to seafood/fish or corn oil; Allergy to bovine gelatine or glycerine (softgel components); Allergy to Xylocaine (anesthesia used during fat tissue biopsy); Other conditions deemed inappropriate by the study physician (e.g. difficulties in understanding/communicating in French or English); Diabetes or HbA1c ≥ 6.5%; 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; Systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg; Reactive hypoglycaemia; Chronic diarrhea; Cholecystectomy (e.g. removal of gall bladder); Sleep apnea; 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; Lack of time to participate in the full length of the study (18-22 weeks).

ClinicalTrials.gov NCT07575438