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

April 22, 2024 updated by: Pinakin Davey, Western University of Health Sciences

Efficacy of OmegaBoost to Increase Omega-3 Levels Particularly Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) in Healthy Individuals as Compared to the Leading Omega-3 Softgel and the Leading Omega-3 Gummy

The purpose of this study is to determine increases in the Omega Index test indicating optimal Omega-3s particularly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) levels for overall systemic benefits including healthy cardiovascular health and cholesterol levels as shown in the OmegaIndex (OmegaQuant) research.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

130

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 States
    • California
      • Pomona, California, United States, 91766
        • Western University of Health 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • not currently taking Omega-3 supplements or fish oils
  • able to swallow softgel or chew gummies nutritional supplement daily for a 12 week period
  • able to make four (4) follow-up visits

Exclusion Criteria:

  • allergy to fish or seafood
  • h/o Atrial fibrillation, or at risk of Afib
  • h/o congestive heart failure, heart disease, or prior myocardial infarction and/or cerebrovascular accident
  • noncompliance with study requirements

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OmegaBoost (QD)
Participants assigned the study supplement OmegaBoost, taken once daily (QD).
Dietary supplement: OmegaBoost

An ultra-pure omega-3 fish oil supplement with no fishy aftertaste and no fish burps.

10x more omega-3 from fish oil than the leading omega-3 gummies. Gel bites have better absorption than ordinary, hard-to-swallow fish oil pills.
Experimental: OmegaBoost (BID)
Participants assigned the study supplement OmegaBoost, taken twice daily (BID).
Dietary supplement: OmegaBoost

An ultra-pure omega-3 fish oil supplement with no fishy aftertaste and no fish burps.

10x more omega-3 from fish oil than the leading omega-3 gummies. Gel bites have better absorption than ordinary, hard-to-swallow fish oil pills.
Active Comparator: Nature Made (soft gel)
Participants assigned the Nature Made (soft gel), taken twice daily.
Dietary supplement: Nature Made (soft gel)
A commercially-available omega-3 soft gel formula
Active Comparator: Nature Made (gummy)
Participants assigned the Nature Made (gummy), taken twice daily.
Dietary supplement: Nature Made (gummy)
A commercially-available omega-3 formula in gummy form

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Changes in Omega-3 Index (OmegaQuant)
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
OmegaQuant provides Omega Index which is a percentage of omega 3 fatty acids particularly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in the erythrocytes. The baseline values of OmegaIndex will be compared to repeated measurements obtained at at a 4-, 8- and 12-week. The OmegaQuant labs in Sioux Falls, SD analyze the blood samples to obtain omega-3 levels, omega-6 fatty acids, cis-Monounsaturated Fatty Acids, saturated fatty acids, trans fatty acids. Additionally, arachidonic acid to eicosapentaenoic acid ratio and omega 3 to omega 6 ratios will be calculated
Baseline, 4 weeks, 8 weeks, and 12 weeks
Mean Changes in omega 3 to omega 6 ratios
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
The baseline values of omega 3 to omega 6 ratios provided by the blood erythrocyte testing performed the OmegaQuant test will be compared to repeated measurements obtained at a 4-, 8- and 12-week.
Baseline, 4 weeks, 8 weeks, and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Changes in General Health Questionnaire
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Eligible participants will be asked to complete the General Health Questionnaire during each visit to monitor secondary observational improvements and overall compliance. The questionnaire will assess: overall health & wellbeing, overall mood, energy level, stress, mental focus, joint health; along with changes in skin, hair, nails, and dry eye (if applicable). With a lower score considered to be a worse outcome
Baseline, 4 weeks, 8 weeks, and 12 weeks
Mean changes to Hb a1c with Omega Boost supplementation
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
For the once daily group Baseline Hba1c is evaluated and will be repeated at various time points that is 4, 8 and 12 weeks. The groups will be compared. A reduction or decrease in values over time is considered an improvement.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Mean changes to total cholesterol with Omega Boost supplementation
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
For the once-daily group, baseline total cholesterol is evaluated and will be repeated at various time points that is 4 weeks, 8 weeks, and 12 weeks. The groups will be compared. A reduction or decrease in values over time is considered an improvement.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Mean changes to low-density lipoprotein with Omega Boost supplementation
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
For the once-daily group, baseline low-density lipoprotein is evaluated and will be repeated at various time points which are 4 weeks, 8 weeks, and 12 weeks. The groups will be compared. A reduction or decrease in values over time is considered an improvement.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Mean changes to high-density lipoprotein with Omega Boost supplementation
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
For the once-daily group baseline high-density lipoprotein is evaluated and will be repeated at various time points that is 4 weeks, 8 weeks, and 12 weeks. The groups will be compared. An increase in values over time is considered an improvement.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Mean changes to triglycerides with Omega Boost supplementation
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
For the once-daily group baseline triglycerides is evaluated and will be repeated at various time points which are 4 weeks, 8 week, and 12 weeks. The groups will be compared. A reduction or decrease in values over time is considered an improvement.
Baseline, 4 weeks, 8 weeks, and 12 weeks

Collaborators and Investigators

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

Sponsor

Western University of Health Sciences

Collaborators

Guardion Health Sciences, Inc.

Investigators

  • Principal Investigator: Pinakin Gunvant Davey, PhD, OD, Western University of Health Sciences

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 (Actual)

May 25, 2022

Primary Completion (Estimated)

May 25, 2024

Study Completion (Estimated)

June 25, 2024

Study Registration Dates

First Submitted

February 26, 2023

First Submitted That Met QC Criteria

March 8, 2023

First Posted (Actual)

March 10, 2023

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GHS.002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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