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| Name | Class |
|---|---|
| Guardion Health Sciences, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OmegaBoost (QD) | Experimental | Participants assigned the study supplement OmegaBoost, taken once daily (QD). |
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| OmegaBoost (BID) | Experimental | Participants assigned the study supplement OmegaBoost, taken twice daily (BID). |
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| Nature Made (soft gel) | Active Comparator | Participants assigned the Nature Made (soft gel), taken twice daily. |
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| Nature Made (gummy) | Active Comparator | Participants assigned the Nature Made (gummy), taken twice daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pinakin Gunvant Davey, PhD, OD | Western University of Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western University of Health Sciences | Pomona | California | 91766 | United States |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
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Parallel treatment group participants will be randomly assigned either the experimental interventions;
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| Nature Made (soft gel) | Dietary Supplement | A commercially-available omega-3 soft gel formula |
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| Nature Made (gummy) | Dietary Supplement | A commercially-available omega-3 formula in gummy form |
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| 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 |