Effect of Omega-3 Fatty Acids on Eye Blood Vessels in Type 1 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2026-07-30

Brief Summary

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The aim of this clinical trial is to learn if omega-3 fatty acid supplements help maintain healthy blood vessels in the eyes of adults with type 1 diabetes. It will also learn about the safety of omega-3 supplements. The main questions it aims to answer are:

Do omega-3 supplements improve the health of retinal blood vessels in adults with type 1 diabetes? Are there any side effects when taking omega-3 supplements? Researchers will compare participants taking omega-3 supplements to a control group (if applicable) to see if the supplements help support retinal blood vessel health.

Participants will:

Take a daily omega-3 supplement for the duration of the study Attend regular eye exams to monitor changes in the retina Report any side effects or health changes during the study

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Detailed Description

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People with type 1 diabetes are at risk of having changes in microvasculature of the retina, which may impair visual functions with time. This paper examines the potential of daily supplemental intake of omega -3 fatty acids to maintain retinal vascularity and prevent the ocular complications linked to diabetes. The researchers seek to know whether the supplements can protect the eyes and enhance the long-term eye health.

The trial participants will consume a daily dose of omega 3 and visit a clinic after every quarterly interval to take ophthalmic tests. In the process of such appointments the research team will examine the health of the retinal and record any vascular changes. Another questionnaire that will be administered to the participants is the one that focuses on adverse events, including mild gastrointestinal discomfort, linked to supplementation.

The trial period will take around 12 months. The control cohort will be assigned to the non-supplemented group in order to compare the differences in retinal microvascular health in subjects subjected to omega-3 supplementation. The results although may not have immediate therapeutic value would inform future interventions to prevent or mitigate ocular complications in people with type 1 diabetes.

Conditions

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Diabetic Retinopathy Type 1 Diabetes Omega 3 Fatty Acids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned to either the omega-3 supplement group or a control group that does not receive the supplement. Both groups will attend regular eye exams every three months to monitor changes in retinal blood vessels. Outcomes will be compared between the two groups to assess the effects of omega-3 supplementation

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Laboratory staff analyzing blood samples and retinal imaging technicians will be blinded to group assignments

Study Groups

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Omega-3 Supplement Group

Participants will take one daily capsule containing 1000 mg of combined EPA and DHA. The supplement is taken orally with food. Eye exams will be performed every three months to monitor retinal blood vessel health.

Group Type EXPERIMENTAL

Omega 3 Fish Oil supplements

Intervention Type DIETARY_SUPPLEMENT

Arm 1 - Omega-3 Supplement Group:

Intervention Type: Dietary Supplement Intervention Name: Omega-3 Fatty Acid Supplement

Intervention Description:

Participants will take one daily capsule containing 1000 mg of combined EPA and DHA. The supplement is taken orally with food. Eye exams will be performed every three months to monitor retinal blood vessel health. Participants will report any side effects such as mild stomach upset.

Arm 2 - Placebo / Control Group:

Intervention Type: Placebo Intervention Name: Placebo Capsule

Intervention Description:

Participants will take a daily capsule that looks identical to the omega-3 supplement but contains no active omega-3 fatty acids. Eye exams will be performed every three months to monitor retinal blood vessel health. Participants will report any health changes.

Omega-3 Control Group

Participants will take a daily capsule that looks identical to the omega-3 supplement but contains no active omega-3 fatty acids. Eye exams will be performed every three months to monitor retinal blood vessel health. Participants will report any health changes.

Group Type PLACEBO_COMPARATOR

Omega 3 Fish Oil supplements

Intervention Type DIETARY_SUPPLEMENT

Arm 1 - Omega-3 Supplement Group:

Intervention Type: Dietary Supplement Intervention Name: Omega-3 Fatty Acid Supplement

Intervention Description:

Participants will take one daily capsule containing 1000 mg of combined EPA and DHA. The supplement is taken orally with food. Eye exams will be performed every three months to monitor retinal blood vessel health. Participants will report any side effects such as mild stomach upset.

Arm 2 - Placebo / Control Group:

Intervention Type: Placebo Intervention Name: Placebo Capsule

Intervention Description:

Participants will take a daily capsule that looks identical to the omega-3 supplement but contains no active omega-3 fatty acids. Eye exams will be performed every three months to monitor retinal blood vessel health. Participants will report any health changes.

Interventions

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Omega 3 Fish Oil supplements

Arm 1 - Omega-3 Supplement Group:

Intervention Type: Dietary Supplement Intervention Name: Omega-3 Fatty Acid Supplement

Intervention Description:

Participants will take one daily capsule containing 1000 mg of combined EPA and DHA. The supplement is taken orally with food. Eye exams will be performed every three months to monitor retinal blood vessel health. Participants will report any side effects such as mild stomach upset.

Arm 2 - Placebo / Control Group:

Intervention Type: Placebo Intervention Name: Placebo Capsule

Intervention Description:

Participants will take a daily capsule that looks identical to the omega-3 supplement but contains no active omega-3 fatty acids. Eye exams will be performed every three months to monitor retinal blood vessel health. Participants will report any health changes.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Placebo

Eligibility Criteria

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Inclusion Criteria

Diagnosis of Type 1 Diabetes Age between 10 and 45 years Duration of diabetes ≥ 2 years Mild to moderate diabetic retinopathy allowed (based on fundus examination)

Exclusion Criteria

Presence of any ocular disease other than diabetic retinopathy Use of medications that may affect retinal vascular measurements or visual function outcomes Presence of systemic diseases other than diabetes (e.g., uncontrolled hypertension, autoimmune diseases) History of ocular surgery within the past 6 months Current participation in another interventional clinical trial

Minimum Eligible Age

10 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No