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

NCT05763940 | Active Not Recruiting

• 1 other identifier: GHS.002
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

  Baseline, 4 weeks, 8 weeks, and 12 weeks

• 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.

  Baseline, 4 weeks, 8 weeks, and 12 weeks

Secondary Outcomes (6)

• Mean Changes in General Health Questionnaire

  Baseline, 4 weeks, 8 weeks, and 12 weeks

• Mean changes to Hb a1c with Omega Boost supplementation

  Baseline, 4 weeks, 8 weeks, and 12 weeks

• Mean changes to total cholesterol with Omega Boost supplementation

  Baseline, 4 weeks, 8 weeks, and 12 weeks

• Mean changes to low-density lipoprotein with Omega Boost supplementation

  Baseline, 4 weeks, 8 weeks, and 12 weeks

• Mean changes to high-density lipoprotein with Omega Boost supplementation

  Baseline, 4 weeks, 8 weeks, and 12 weeks

Study Arms (4)

OmegaBoost (QD)

EXPERIMENTAL

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

Dietary Supplement: OmegaBoost

OmegaBoost (BID)

EXPERIMENTAL

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

Dietary Supplement: OmegaBoost

Nature Made (soft gel)

ACTIVE COMPARATOR

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

Dietary Supplement: Nature Made (soft gel)

Nature Made (gummy)

ACTIVE COMPARATOR

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

Dietary Supplement: Nature Made (gummy)

Interventions

OmegaBoost 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); OmegaBoost (QD)

Nature Made (soft gel) DIETARY_SUPPLEMENT

A commercially-available omega-3 soft gel formula

Nature Made (soft gel)

Nature Made (gummy) DIETARY_SUPPLEMENT

A commercially-available omega-3 formula in gummy form

Nature Made (gummy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Western University of Health Sciences: lead
• Guardion Health Sciences, Inc.: collaborator

Study Sites (1)

Western University of Health Sciences

Pomona, California, 91766, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Macular Degeneration

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Retinal Degeneration; Retinal Diseases

Study Officials

• Pinakin Gunvant Davey, PhD, OD

  Western University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

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

Study Record Dates

• First Submitted: February 26, 2023
• First Posted: March 10, 2023
• Study Start: May 25, 2022
• Primary Completion: May 25, 2024
• Study Completion: June 25, 2024
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)