NCT05267301

AlmegaPL CV Health Open Label Study

Open Label Post-market Evaluation of Orally Dosed AlmegaPL on Cholesterol and Cardio-metabolic Parameters.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Qualitas Health · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to assess the effectiveness of Almega PL, a Nannochloropsis algae-derived extract rich in eicosapentaenoic acid (EPA), on improving blood markers associated with heart health of iwi customers.

Detailed description

The investigational product iwi/Cholesterol is a commercially available capsule-form herbal (algae) supplement containing Almega®PL, a Nannochloropsis algae-derived extract rich in eicosapentaenoic acid (EPA). EPA is a type of omega-3 essential fatty acid known to play a beneficial role in protection against cardiovascular disease.The aim of this study is to assess the effectiveness of AlmegaPL on improving blood markers associated with heart health of iwi customers.The study will involve over 200 male and female new consumers of this product and monitor their blood markers during 6 months of supplementation.

Conditions

• Cholesterol
• Triglycerides
• Omega-3
• Eicosapentaenoic Acid

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	AlmegaPL (FDA NDIN # 826)	The investigational product iwi/Cholesterol is a commercially available capsule-form herbal (algae) supplement containing Almega®PL, a Nannochloropsis algae-derived extract rich in eicosapentaenoic acid (EPA). EPA is a type of omega-3 essential fatty acid known to play a beneficial role in protection against cardiovascular disease. Iwi/Cholesterol is the only source of long chain omega-3 that does not contain the DHA that is present in other omega-3 sources (fish oil, krill oil, other algal oils). Almega®PL was registered at the Food and Drug Administration (FDA) as a New Dietary Ingredient (NDIN) in 2014.

Timeline

• Start date: 2022-05-11
• Primary completion: 2022-11-14
• Completion: 2022-12-01
• First posted: 2022-03-04
• Last updated: 2024-02-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study