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

Study Overview
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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.

Official Title
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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

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

Intervention / Treatment
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* Dietary Supplement: OmegaBoost
* Dietary Supplement: Nature Made (soft gel)
* Dietary Supplement: Nature Made (gummy)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel treatment group participants will be randomly assigned either the experimental interventions;
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OmegaBoost (QD)<br>Participants assigned the study supplement OmegaBoost, taken once daily (QD). | Dietary Supplement: OmegaBoost<br>* 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.<br>|
| Experimental: OmegaBoost (BID)<br>Participants assigned the study supplement OmegaBoost, taken twice daily (BID). | Dietary Supplement: OmegaBoost<br>* 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.<br>|
| Active Comparator: Nature Made (soft gel)<br>Participants assigned the Nature Made (soft gel), taken twice daily. | Dietary Supplement: Nature Made (soft gel)<br>* A commercially-available omega-3 soft gel formula<br>|
| Active Comparator: Nature Made (gummy)<br>Participants assigned the Nature Made (gummy), taken twice daily. | Dietary Supplement: Nature Made (gummy)<br>* A commercially-available omega-3 formula in gummy form<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline, 4 weeks, 8 weeks, and 12 weeks | 
| 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. | Baseline, 4 weeks, 8 weeks, and 12 weeks | 
| 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. | Baseline, 4 weeks, 8 weeks, and 12 weeks | 
| 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. | Baseline, 4 weeks, 8 weeks, and 12 weeks | 
| 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. | Baseline, 4 weeks, 8 weeks, and 12 weeks | 
| 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. | Baseline, 4 weeks, 8 weeks, and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DHA, Omega-3s, Docosahexaenoic acid, Eicosapentaenoic acid, EPA, OmegaBoost, Omega Index test