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

NCT ID: NCT05763940

Last Updated: 2024-04-24

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-25

Study Completion Date

2024-06-25

Brief Summary

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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.

Detailed Description

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Conditions

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Dry Eye Syndromes Age-Related Macular Degeneration Omega 3 Index

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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OmegaBoost (QD)

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

Group Type EXPERIMENTAL

OmegaBoost

Intervention Type DIETARY_SUPPLEMENT

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.

OmegaBoost (BID)

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

Group Type EXPERIMENTAL

OmegaBoost

Intervention Type DIETARY_SUPPLEMENT

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.

Nature Made (soft gel)

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

Group Type ACTIVE_COMPARATOR

Nature Made (soft gel)

Intervention Type DIETARY_SUPPLEMENT

A commercially-available omega-3 soft gel formula

Nature Made (gummy)

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

Group Type ACTIVE_COMPARATOR

Nature Made (gummy)

Intervention Type DIETARY_SUPPLEMENT

A commercially-available omega-3 formula in gummy form

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Nature Made (soft gel)

A commercially-available omega-3 soft gel formula

Intervention Type DIETARY_SUPPLEMENT

Nature Made (gummy)

A commercially-available omega-3 formula in gummy form

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Guardion Health Sciences, Inc.

INDUSTRY

Sponsor Role collaborator

Western University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Pinakin Davey

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pinakin Gunvant Davey, PhD, OD

Role: PRINCIPAL_INVESTIGATOR

Western University of Health Sciences

Locations

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Western University of Health Sciences

Pomona, California, United States

Site Status

Countries

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United States

Other Identifiers

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GHS.002

Identifier Type: -

Identifier Source: org_study_id

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