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- Klinische proef NCT07753174
A Clinical Trial to Evaluate the Effects of an Omega-3-containing Supplement on DHA and EPA Levels in the Blood
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Patrick Renner
- Telefoonnummer: 4242450284
Studie Locaties
-
-
Nevada
-
Las Vegas, Nevada, Verenigde Staten, 89101
- Werving
- Citruslabs
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Omega Active Supplement
|
All participants receive one dose (two capsules) of the Omega Active omega-3 supplement daily for 12 weeks.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in DHA levels in the blood
Tijdsspanne: Baseline and Week 12
|
Change from Baseline in DHA blood concentration as assessed by blood biomarker testing (test code 92701) at Quest Diagnostics Center
|
Baseline and Week 12
|
|
Change in EPA levels in the blood
Tijdsspanne: Baseline and Week 12
|
Change from Baseline in EPA blood concentration as assessed by blood biomarker testing (test code 92701) at Quest Diagnostics Center
|
Baseline and Week 12
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in self-reported cognitive performance
Tijdsspanne: 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
|
Baseline, Week 4, Week 8, and Week 12
|
|
Change in self-reported gastrointestinal symptoms
Tijdsspanne: Baseline, Week 4, Week 8, and Week 12
|
Participant-reported occurrence of gastrointestinal symptoms, including acid reflux, as assessed by self-reported questionnaire
|
Baseline, Week 4, Week 8, and Week 12
|
|
Change in self-reported overall health and well-being
Tijdsspanne: Baseline, Week 4, Week 8, and Week 12
|
Participant-reported perceptions of overall health and well-being as assessed by self-reported questionnaire
|
Baseline, Week 4, Week 8, and Week 12
|
|
Participant experience with consumption of the test product
Tijdsspanne: 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
|
Baseline, Week 4, Week 8, and Week 12
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 20833
- legacy-20833
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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