A Clinical Trial to Evaluate the Effects of an Omega-3-containing Supplement on DHA and EPA Levels in the Blood
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Omega Active Supplement.
- Who it may be relevant to
- Registry conditions: Omega-3 Deficiency, DHA and EPA Blood Levels, Cardiovascular Health, Cognitive Health. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 supplement Omega Active Supplement
All participants receive one dose (two capsules) of the Omega Active omega-3 supplement daily for 12 weeks.
Primary outcome measures
- Change in DHA levels in the blood [Time frame: Baseline and Week 12]
- Change in EPA levels in the blood [Time frame: Baseline and Week 12]
Secondary outcome measures (4)
- Change in self-reported cognitive performance [Time frame: Baseline, Week 4, Week 8, and Week 12]
- Change in self-reported gastrointestinal symptoms [Time frame: Baseline, Week 4, Week 8, and Week 12]
- Change in self-reported overall health and well-being [Time frame: Baseline, Week 4, Week 8, and Week 12]
- Participant experience with consumption of the test product [Time frame: Baseline, Week 4, Week 8, and Week 12]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Citruslabs — Las Vegas
Identifiers
NCT: NCT07753174 · 20833 · legacy-20833