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

Age-Related Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05763940
• Other study ID #: GHS.002
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 25, 2022
• Est. completion date: June 25, 2024

Study information

• Verified date: April 2024
• Source: Western University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: June 25, 2024
• Est. primary completion date: May 25, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Dry Eye Syndromes
• Macular Degeneration

Intervention

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.
• Nature Made (soft gel)
A commercially-available omega-3 soft gel formula
• Nature Made (gummy)
A commercially-available omega-3 formula in gummy form

Locations

Country	Name	City	State
United States	Western University of Health Sciences	Pomona	California

Sponsors (2)

Lead Sponsor	Collaborator
Western University of Health Sciences	Guardion Health Sciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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