Dry Eye SyndromesNCT05763940
Efficacy of OmegaBoost to Increase Omega-3 Levels in Healthy Individuals
A study testing OmegaBoost, Nature Made (soft gel) and Nature Made (gummy) in people with Dry Eye Syndromes and Age-Related Macular Degeneration, run by Western University of Health Sciences at 1 site in United States.
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)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndromes, Age-Related Macular Degeneration, Omega 3 Index
- What is being tested?
- OmegaBoost, Nature Made (soft gel) and Nature Made (gummy)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2022to 25 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Western University of Health Sciences
Pomona, California, 91766
About this study
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
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.
- Being tested
- OmegaBoost, Nature Made (soft gel), Nature Made (gummy)
- Keywords
- Omega-3s, Docosahexaenoic acid, DHA, Eicosapentaenoic acid, EPA, OmegaBoost, Omega Index test
- Medical subject headings
- Dry Eye Syndromes, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmegaBoostDietary 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.
Nature Made (soft gel)Dietary supplement
A commercially-available omega-3 soft gel formula
Nature Made (gummy)Dietary supplement
A commercially-available omega-3 formula in gummy form
| Study group | Role | What they receive |
|---|---|---|
| OmegaBoost (QD) | Experimental | Participants assigned the study supplement OmegaBoost, taken once daily (QD). Receives: Dietary Supplement: OmegaBoost |
| OmegaBoost (BID) | Experimental | Participants assigned the study supplement OmegaBoost, taken twice daily (BID). Receives: Dietary Supplement: OmegaBoost |
| Nature Made (soft gel) | Active comparator | Participants assigned the Nature Made (soft gel), taken twice daily. Receives: Dietary Supplement: Nature Made (soft gel) |
| Nature Made (gummy) | Active comparator | Participants assigned the Nature Made (gummy), taken twice daily. Receives: Dietary Supplement: Nature Made (gummy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Secondary outcomes (6)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start25 May 2022
- Primary completion25 May 2024 (estimated)
- Study completion25 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel treatment group participants will be randomly assigned either the experimental interventions;
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Guardion Health Sciences, Inc.
- Responsible party
- Principal investigator, Pinakin Davey, Western University of Health Sciences
- Investigators
- Pinakin Gunvant Davey, PhD, OD, Principal investigator, Western University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763940
- Sponsor's protocol ID
- GHS.002
- Status last verified
- Apr 2024
- First submitted
- 26 Feb 2023
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05763940
- Acronym / sponsor ID
- GHS.002
- Keywords
- Omega-3s, Docosahexaenoic acid, DHA, Eicosapentaenoic acid, EPA, OmegaBoost, Omega Index test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Western University of Health SciencesUniversity, hospital or other
- Collaborators
- Guardion Health Sciences, Inc.
- Study start
- 25 May 2022 (actual)
- Primary completion
- 25 May 2024 (estimated)
- Study completion
- 25 Jun 2024 (estimated)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Parallel treatment group participants will be randomly assigned either the experimental interventions;
| Arm | Type | Receives |
|---|---|---|
| OmegaBoost (QD) | Experimental | Dietary Supplement: OmegaBoostParticipants assigned the study supplement OmegaBoost, taken once daily (QD). |
| OmegaBoost (BID) | Experimental | Dietary Supplement: OmegaBoostParticipants assigned the study supplement OmegaBoost, taken twice daily (BID). |
| Nature Made (soft gel) | Active comparator | Dietary Supplement: Nature Made (soft gel)Participants assigned the Nature Made (soft gel), taken twice daily. |
| Nature Made (gummy) | Active comparator | Dietary Supplement: Nature Made (gummy)Participants assigned the Nature Made (gummy), taken twice daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmegaBoostAn 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 supplement | OmegaBoost (BID), OmegaBoost (QD) |
| Nature Made (soft gel)A commercially-available omega-3 soft gel formula | Dietary supplement | Nature Made (soft gel) |
| Nature Made (gummy)A commercially-available omega-3 formula in gummy form | Dietary supplement | Nature Made (gummy) |
Primary outcome
Mean Changes in Omega-3 Index (OmegaQuant)
Time frame: 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
Time frame: 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.
6 secondary outcomes
Mean Changes in General Health Questionnaire
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Mean changes to Hb a1c with Omega Boost supplementation
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Mean changes to total cholesterol with Omega Boost supplementation
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Mean changes to low-density lipoprotein with Omega Boost supplementation
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Mean changes to high-density lipoprotein with Omega Boost supplementation
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Mean changes to triglycerides with Omega Boost supplementation
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Dry Eye Syndromes
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Not yet recruitingPhase 2
Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments
Dry Eye Disease (DED), Graft-Versus-Host Disease(GVHD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pinakin Gunvant Davey, PhD, OD principal investigator
Western University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OmegaBoost, Nature Made (soft gel) and Nature Made (gummy) in people with Dry Eye Syndromes and Age-Related Macular Degeneration, run by Western University of Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Changes in Omega-3 Index (OmegaQuant) (time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.