← Back to Search

Omega-3 Fatty Acid Supplement

OmegaBoost (QD) for Dry Eye Syndrome

N/A

Waitlist Available

Led By Pinakin Gunvant Davey, PhD, OD

Research Sponsored by Western University of Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Not currently taking Omega-3 supplements or fish oils

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 4 weeks, 8 weeks, and 12 weeks

Awards & highlights

Study Summary

This trial looks at how Omega-3 levels affect heart health and cholesterol. It aims to determine optimal levels of Omega-3s (EPA & DHA) for overall health benefits.

Who is the study for?

This trial is for healthy individuals who can attend four follow-up visits, are not currently taking Omega-3 supplements or fish oils, and can swallow softgels or chew gummy supplements daily for 12 weeks. It's not suitable for those with a history of heart failure, heart disease, stroke, atrial fibrillation risks, noncompliance with study protocols, or allergies to fish/seafood.Check my eligibility

What is being tested?

The trial tests the effectiveness of OmegaBoost in raising Omega-3 levels (EPA and DHA) which may benefit cardiovascular health and cholesterol levels. Participants will receive either OmegaBoost or Nature Made products (in gummy or soft gel form) to compare their impact on the Omega Index test results.See study design

What are the potential side effects?

While specific side effects aren't listed here, typical reactions might include digestive discomfort due to omega fatty acids intake such as bloating or burping with a fishy aftertaste especially if allergic to fish/seafood.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am not taking Omega-3 or fish oil supplements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 4 weeks, 8 weeks, and 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 4 weeks, 8 weeks, and 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 weeks, 8 weeks, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean Changes in Omega-3 Index (OmegaQuant)

Mean Changes in omega 3 to omega 6 ratios

Secondary outcome measures

Mean Changes in General Health Questionnaire

Mean changes to Hb a1c with Omega Boost supplementation

Mean changes to high-density lipoprotein with Omega Boost supplementation

+3 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: OmegaBoost (QD)Experimental Treatment1 Intervention

Participants assigned the study supplement OmegaBoost, taken once daily (QD).

Group II: OmegaBoost (BID)Experimental Treatment1 Intervention

Participants assigned the study supplement OmegaBoost, taken twice daily (BID).

Group III: Nature Made (soft gel)Active Control1 Intervention

Participants assigned the Nature Made (soft gel), taken twice daily.

Group IV: Nature Made (gummy)Active Control1 Intervention

Participants assigned the Nature Made (gummy), taken twice daily.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Western University of Health SciencesLead Sponsor

23 Previous Clinical Trials

1,225 Total Patients Enrolled

Guardion Health Sciences, Inc.Industry Sponsor

2 Previous Clinical Trials

79 Total Patients Enrolled

Pinakin Gunvant Davey, PhD, ODPrincipal InvestigatorWestern University of Health Sciences

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies in this research project for volunteers?

"The information posted on clinicaltrials.gov suggests that this research project is not presently recruiting participants. Initially published 25th May 2022 and lastly updated 8th March 2023, the study has temporarily ceased recruitment activities; however 258 other trials are actively enrolling patients at present."

Answered by AI

What are the expected results of this experiment?

"The primary endpoint of the study, which will be tracked over Baseline, 4 weeks, 8 weeks and 12 weeks is to evaluate Mean Changes in omega 3 to omega 6 ratios. Secondary outcomes include assessing changes to Hb a1c with Omega Boost supplementation (evaluated at Baseline and repeated every four weeks), total cholesterol levels (measured also measured at intervals of four week) as well as low-density lipoprotein readings (assessed similarly on a monthy basis). A reduction or decrease in values over time is seen as an improvement for each metric."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy of OmegaBoost to Increase Omega-3 Levels in Healthy Individuals

Pinakin Davey 2022. "Efficacy of OmegaBoost to Increase Omega-3 Levels in Healthy Individuals". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05763940.