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

Sponsor

Western University of Health Sciences (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05763940

Collaborator

Guardion Health Sciences, Inc. (Industry)

130

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes Age-Related Macular Degeneration Omega 3 Index	Dietary Supplement: OmegaBoost Dietary Supplement: Nature Made (soft gel) Dietary Supplement: Nature Made (gummy)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

May 25, 2022

Anticipated Primary Completion Date :

May 25, 2023

Anticipated Study Completion Date :

Jun 25, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Mean Changes in Omega-3 Index (OmegaQuant) [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
Mean Changes in omega 3 to omega 6 ratios [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.

Secondary Outcome Measures

Mean Changes in General Health Questionnaire [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
Mean changes to Hb a1c with Omega Boost supplementation [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.
Mean changes to total cholesterol with Omega Boost supplementation [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.
Mean changes to low-density lipoprotein with Omega Boost supplementation [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.
Mean changes to high-density lipoprotein with Omega Boost supplementation [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.
Mean changes to triglycerides with Omega Boost supplementation [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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