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

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Primary Purpose

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

OmegaBoost

Nature Made (soft gel)

Nature Made (gummy)

About this trial

This is an interventional supportive care trial for Dry Eye Syndromes focused on measuring Omega-3s, Docosahexaenoic acid, DHA, Eicosapentaenoic acid, EPA, OmegaBoost, Omega Index test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Western University of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

OmegaBoost (QD)

OmegaBoost (BID)

Nature Made (soft gel)

Nature Made (gummy)

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Mean Changes in Omega-3 Index (OmegaQuant)

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

Mean Changes in omega 3 to omega 6 ratios

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.

Secondary Outcome Measures

Mean Changes in General Health Questionnaire

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

Mean changes to Hb a1c with Omega Boost supplementation

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.

Mean changes to total cholesterol with Omega Boost supplementation

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.

Mean changes to low-density lipoprotein with Omega Boost supplementation

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.

Mean changes to high-density lipoprotein with Omega Boost supplementation

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.

Mean changes to triglycerides with Omega Boost supplementation

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.

Full Information

NCT ID

NCT05763940

First Posted

February 26, 2023

Last Updated

March 8, 2023

Sponsor

Western University of Health Sciences

Collaborators

Guardion Health Sciences, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05763940

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 25, 2022 (Actual)

Primary Completion Date

May 25, 2023 (Anticipated)

Study Completion Date

June 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Western University of Health Sciences

Collaborators

Guardion Health Sciences, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye Syndromes, Age-Related Macular Degeneration, Omega 3 Index

Keywords

Omega-3s, Docosahexaenoic acid, DHA, Eicosapentaenoic acid, EPA, OmegaBoost, Omega Index test

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Parallel treatment group participants will be randomly assigned either the experimental interventions;

Masking

None (Open Label)

Allocation

Randomized

Enrollment

130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

OmegaBoost (QD)

Arm Type

Experimental

Arm Description

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

Arm Title

OmegaBoost (BID)

Arm Type

Experimental

Arm Description

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

Arm Title

Nature Made (soft gel)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Nature Made (gummy)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

OmegaBoost

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Nature Made (soft gel)

Intervention Description

A commercially-available omega-3 soft gel formula

Intervention Type

Dietary Supplement

Intervention Name(s)

Nature Made (gummy)

Intervention Description

A commercially-available omega-3 formula in gummy form

Primary Outcome Measure Information:

Title

Mean Changes in Omega-3 Index (OmegaQuant)

Description

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

Time Frame

Baseline, 4 weeks, 8 weeks, and 12 weeks

Title

Mean Changes in omega 3 to omega 6 ratios

Description

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.

Time Frame

Baseline, 4 weeks, 8 weeks, and 12 weeks

Secondary Outcome Measure Information:

Title

Mean Changes in General Health Questionnaire

Description

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

Time Frame

Baseline, 4 weeks, 8 weeks, and 12 weeks

Title

Mean changes to Hb a1c with Omega Boost supplementation

Description

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.

Time Frame

Baseline, 4 weeks, 8 weeks, and 12 weeks

Title

Mean changes to total cholesterol with Omega Boost supplementation

Description

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.

Time Frame

Baseline, 4 weeks, 8 weeks, and 12 weeks

Title

Mean changes to low-density lipoprotein with Omega Boost supplementation

Description

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.

Time Frame

Baseline, 4 weeks, 8 weeks, and 12 weeks

Title

Mean changes to high-density lipoprotein with Omega Boost supplementation

Description

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.

Time Frame

Baseline, 4 weeks, 8 weeks, and 12 weeks

Title

Mean changes to triglycerides with Omega Boost supplementation

Description

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.

Time Frame

Baseline, 4 weeks, 8 weeks, and 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pinakin Gunvant Davey, PhD, OD

Organizational Affiliation

Western University of Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Western University of Health Sciences

City

Pomona

State/Province

California

ZIP/Postal Code

91766

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

No

Dry Eye Syndromes, Age-Related Macular Degeneration, Omega 3 Index

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial