A Clinical Trial to Evaluate the Effects of an Omega-3-containing Supplement on DHA and EPA Levels in the Blood
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorRevive Active
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Omega Active Supplement
Dietary supplementAll participants receive one dose (two capsules) of the Omega Active omega-3 supplement daily for 12 weeks.
Treatment groups
49 Participants
are divided into 1 treatment groupGroup A: Omega Active SupplementExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in DHA levels in the blood
Change from Baseline in DHA blood concentration as assessed by blood biomarker testing (test code 92701) at Quest Diagnostics Center
Time frame
Baseline and Week 122
Change in EPA levels in the blood
Change from Baseline in EPA blood concentration as assessed by blood biomarker testing (test code 92701) at Quest Diagnostics Center
Time frame
Baseline and Week 12Secondary outcomes
1
Change in self-reported cognitive performance
Participant-reported perceptions of the effects of the test product on cognitive function as assessed by self-reported questionnaire
Time frame
Baseline, Week 4, Week 8, and Week 122
Change in self-reported gastrointestinal symptoms
Participant-reported occurrence of gastrointestinal symptoms, including acid reflux, as assessed by self-reported questionnaire
Time frame
Baseline, Week 4, Week 8, and Week 123
Change in self-reported overall health and well-being
Participant-reported perceptions of overall health and well-being as assessed by self-reported questionnaire
Time frame
Baseline, Week 4, Week 8, and Week 124
Participant experience with consumption of the test product
Participant-reported experience of consuming the test product, including palatability and taste, as assessed by self-reported questionnaire
Time frame
Baseline, Week 4, Week 8, and Week 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Revive Active
Lead sponsor
Citruslabs
Collaborator
Source ClinicalTrials.gov