Age-Related Macular Degeneration, Dry Eye Syndromes, Omega 3 Index
Conditions
Keywords
Omega-3s, Docosahexaenoic acid, DHA, Eicosapentaenoic acid, EPA, OmegaBoost, Omega Index test
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.
Interventions
DIETARY_SUPPLEMENTOmegaBoost
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.
DIETARY_SUPPLEMENTNature Made (soft gel)
A commercially-available omega-3 soft gel formula
DIETARY_SUPPLEMENTNature Made (gummy)
A commercially-available omega-3 formula in gummy form
Sponsors
Guardion Health Sciences, Inc.
Western University of Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Parallel treatment group participants will be randomly assigned either the experimental interventions;
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
| 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 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. |
Countries
United States
Outcome results
None listed