AlmegaPL CV Health Open Label Study

Qualitas Health

Status and phase: Completed; Phase 4

Conditions: Eicosapentaenoic Acid; Cholesterol; Omega-3; Triglycerides

Treatments: Dietary Supplement: AlmegaPL (FDA NDIN # 826)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05267301

ALM-CVH-22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• New iwi/AlmegaPL subscribers.

Exclusion criteria

• Participants that are already taking AlmegaPL.
• Participants with serious conditions including but not limited to kidney, neurological, immunological, liver and gastrointestinal disease, any heart condition or diabetes).
• Any participant attempting conception, pregnant or breastfeeding

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

AlmgaPL

Experimental group

Description:

New consumers of iwi self-elected to start taking 2 capsules a day with 1000 mg of AlmegaPL, containing 250 mg of eicosapentaenoic acid (EPA), 150 mg polar lipids and 15 mg chlorophyll.

Treatment:

Dietary Supplement: AlmegaPL (FDA NDIN # 826)