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

Western University of Health Sciences (WESTERN U)

Status: Active, not recruiting

Conditions: Age-Related Macular Degeneration; Omega 3 Index; Dry Eye Syndromes

Treatments: Dietary Supplement: Nature Made (soft gel); Dietary Supplement: Nature Made (gummy); Dietary Supplement: OmegaBoost

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05763940

GHS.002

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 4 patient groups

OmegaBoost (QD)

Experimental group

Description:

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

Treatment:

Dietary Supplement: OmegaBoost

OmegaBoost (BID)

Experimental group

Description:

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

Treatment:

Dietary Supplement: OmegaBoost

Nature Made (soft gel)

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Nature Made (soft gel)

Nature Made (gummy)

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Nature Made (gummy)