Free Fatty Acid Effects In Type 2 Diabetes

June 30, 2026 updated by: University of Ulster

Repositioning Omega-3 Fatty Acids For Treatment Of Glycaemia And Cardiometabolic Disease

Omega-3 fatty acids are natural fats found in foods such as oily fish and flaxseed. Omega-3 fatty acids have been found to have positive effects on cardiovascular health, but there is less evidence on if they can help manage blood glucose in individuals with both cardiovascular disease and type 2 diabetes.

This study will investigate whether the beneficial effects found in omega-3 fatty acids such as lowered blood glucose and reduced inflammation - both of which are important for managing type 2 diabetes and cardiovascular disease, can be beneficial for individuals with type 2 diabetes. As omega-3 fatty acids are already found naturally in food, and are already available as supplements, they could be a safe option to help manage these diseases.

The aim of this study is to investigate if omega-3 fatty acids can slow down the progression of type 2 diabetes and reduce the risk of cardiovascular disease in individuals with type 2 diabetes.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • County Londonderry
      • Coleraine, County Londonderry, United Kingdom, BT52 1SA
        • School of Biomedical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Individuals who are over 18 years of age with a BMI between 25-50 kg/m2, and who have been diagnosed with T2DM (>7.0 mmol/l fasting glucose) or pre-diabetes (impaired glucose tolerant 5.0-6.9mmol/l) and are either on no medication, are diet controlled or taking metformin. Participants may also have a history of cardiovascular disease.

Exclusion Criteria:

  • Those who have severe or unstable cardiovascular disease
  • Type 2 diabetics or prediabetics who are on an anti-diabetic medication (with the exception of metformin)
  • Undergone recent major surgery or planned surgery during the study period
  • Have implanted devices (such as pacemakers or defibrillators)
  • Have an active infection
  • Are involved in any other type of weight loss study/intervention
  • Are pregnant/breastfeeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo
Receive placebo
Experimental: Omega-3 Fatty Acid Supplementation (EPA/DHA)
Dietary supplement: Omega-3 Fatty Acids
1500mg/day for 28 days
Experimental: Omega-3 Fatty Acid Supplementation (ALA)
Dietary supplement: Omega-3 Fatty Acids
1500mg/day for 28 days
Experimental: Omega-3 Fatty Acid Supplementation (EPA/DHA) and Semaglutide
Semaglutide is being used for comparison purposes only
Dietary supplement: Omega-3 Fatty Acids
1500mg/day for 28 days
Drug: Semaglutide 0.25 mg
0.25mg weekly for four weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the change in fasting glucose from baseline after 28 days of treatment, compared to each treatment group and placebo.
Time Frame: From baseline to 28 days of treatment
From baseline to 28 days of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in insulin compared to placebo administration
Time Frame: From baseline to 28 days of treatment
From baseline to 28 days of treatment
The change in HbA1c compared to placebo administration
Time Frame: From baseline to 28 days of treatment
From baseline to 28 days of treatment
Glucose tolerance measurements during OGTT compared to placebo administration
Time Frame: From baseline to 28 days of treatment
From baseline to 28 days of treatment
Area under the curve measurements during OGTT compared to placebo administration
Time Frame: From baseline to 28 days of treatment
From baseline to 28 days of treatment
Plasma gut hormone concentrations (GLP-1, GIP, PYY, ghrelin, CCK and glucagon) compared to placebo administration
Time Frame: From baseline to 28 days of treatment
From baseline to 28 days of treatment
Full lipid profile (cardiovascular risk markers) compared to placebo administration
Time Frame: From baseline to 28 days of treatment
From baseline to 28 days of treatment
Inflammatory and cardiovascular markers compared to placebo administration
Time Frame: From baseline to 28 days of treatment
Biomarkers include inflammatory markers (C-reactive protein [CRP], pro- and anti-inflammatory cytokines) and cardiovascular risk markers
From baseline to 28 days of treatment
Liver function tests (ALT and AST) compared to placebo administration
Time Frame: From baseline to 28 days of treatment
From baseline to 28 days of treatment
Body mass index (BMI) compared to placebo administration
Time Frame: From baseline to 28 days of treatment
Weight (kg) and height (m) will be combined to report BMI in kg/m^2
From baseline to 28 days of treatment
Waist-to-hip circumference compared to placebo administration
Time Frame: From baseline to 28 days of treatment
Waist circumference (in cm between the lower rib and iliac crest) and hip circumference (in cm at the widest part of the hips/buttocks) will be combined to calculate waist-to-hip circumference
From baseline to 28 days of treatment
Blood pressure compared to placebo administration
Time Frame: From baseline to 28 days of treatment
From baseline to 28 days of treatment
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) index compared to placebo administration
Time Frame: From baseline to 28 days of treatment
Insulin resistance will be measured by calculating HOMA-IR using the formula: HOMA-IR = fasting plasma glucose (mg/dL) x fasting plasma insulin/405. Higher values indicate greater insulin resistance. This is a derived continuous index with no fixed minimum or maximum value.
From baseline to 28 days of treatment
Change in Omega-3 Index (EPA and DHA as a percentage of total fatty acids) compared to placebo administration
Time Frame: From baseline to 28 days of treatment
From baseline to 28 days of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulster

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

May 27, 2026

First Submitted That Met QC Criteria

June 30, 2026

First Posted (Actual)

July 1, 2026

Study Record Updates

Last Update Posted (Actual)

July 1, 2026

Last Update Submitted That Met QC Criteria

June 30, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26/ES/0021
  • TA/PPA/25/215037 (Other Grant/Funding Number: British Heart Foundation)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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