Cardiovascular Health, Cognitive Health, DHA and EPA Blood Levels, Omega-3 Deficiency
Conditions
Brief summary
This is a 12-week, hybrid, single-arm clinical trial designed to evaluate the effects of an omega-3-containing supplement (Omega Active) on DHA and EPA levels in the blood. Forty participants will take two capsules of the test product daily and complete study-specific questionnaires at Baseline, Week 4, Week 8, and Week 12, while also attending their local Quest Diagnostics Center at Baseline and Week 12 for blood biomarker testing. The study will also assess participants' perceptions of the effects of the test product on cognitive performance, gastrointestinal symptoms, and overall health through self-reported questionnaires. There is no randomization or blinding; all participants will receive the active supplement for the full 12-week intervention period.
Interventions
DIETARY_SUPPLEMENTOmega Active Supplement
All participants receive one dose (two capsules) of the Omega Active omega-3 supplement daily for 12 weeks.
Sponsors
Revive Active
Citruslabs
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Be male or female. * Be aged 18-65. * Anyone in good general health. * Willing to avoid taking other supplements, prescription medications, or herbal remedies that target DHA or EPA levels in the body, for the duration of the study. * Must not have taken fish oil or plant-based omega oil supplements in the past eight weeks. * Willing to maintain their current diet, sleep schedule, and activity level for the duration of the study. * Resides in the United States.
Exclusion criteria
* Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders. * Anyone on anticoagulants or antiplatelet therapy. * Anyone with a bleeding disorder. * Anyone with any allergies or sensitivities to any of the study product ingredients. * Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period). * Anyone unwilling to follow the study protocol. * Anyone who does not consume any specific dietary ingredients for any reason. * Currently partaking in another research study or will be partaking in any other research study at any point during this study's duration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in DHA levels in the blood | Baseline and Week 12 | Change from Baseline in DHA blood concentration as assessed by blood biomarker testing (test code 92701) at Quest Diagnostics Center |
| Change in EPA levels in the blood | Baseline and Week 12 | Change from Baseline in EPA blood concentration as assessed by blood biomarker testing (test code 92701) at Quest Diagnostics Center |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in self-reported cognitive performance | Baseline, Week 4, Week 8, and Week 12 | Participant-reported perceptions of the effects of the test product on cognitive function as assessed by self-reported questionnaire |
| Change in self-reported gastrointestinal symptoms | Baseline, Week 4, Week 8, and Week 12 | Participant-reported occurrence of gastrointestinal symptoms, including acid reflux, as assessed by self-reported questionnaire |
| Change in self-reported overall health and well-being | Baseline, Week 4, Week 8, and Week 12 | Participant-reported perceptions of overall health and well-being as assessed by self-reported questionnaire |
| Participant experience with consumption of the test product | Baseline, Week 4, Week 8, and Week 12 | Participant-reported experience of consuming the test product, including palatability and taste, as assessed by self-reported questionnaire |
Countries
United States
Contacts
CONTACTPatrick Renner
Outcome results
None listed