Fish Oil for Type 2 Diabetes

(END-T2D Trial)

JF
Cc
Overseen ByClinical coordinator and nurse
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

MF

May Faraj, P.Dt., Ph.D.

Principal Investigator

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

Are You a Good Fit for This Trial?

Inclusion Criteria

* 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
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo specialized metabolic testing to assess glucose processing and fat tissue response

1 week
2 visits (in-person)

Treatment

Participants take softgel capsules containing EPA, DHA, or placebo daily for 12 weeks

12 weeks
6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

3

Treatment groups

Active Control

Placebo Group

Group I: Docosahexaenoic acid (DHA)Active Control1 Intervention
Group II: Eicosapentaenoic acid (EPA)Active Control1 Intervention
Group III: Corn oilPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

May Faraj, PDt, PhD

Lead Sponsor

Trials
1
Recruited
40+

Diabetes Canada

Collaborator

Trials
13
Recruited
1,200+