AlmegaPL CV Health Open Label Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cholesterol, Triglycerides, Omega-3, Eicosapentaenoic Acid

Intervention / Treatment
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* Dietary Supplement: AlmegaPL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Self elected consumers who choose to purchase this product
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AlmgaPL<br>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. | Dietary Supplement: AlmegaPL<br>* 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.<br>* Other names: Nannochloropsis Oil Extract;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglyceride change from baseline | Fasting triglycerides is measured using Imaware at home cardiovascular test kit | From Baseline to Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Cholesterol change from baseline | Fasting total cholesterol is measured using Imaware at home cardiovascular test kit | From Baseline to Month 6 | 
| VLDL-Cholesterol change from Baseline | Fasting VLDL-cholesterol is calculated using results from Imaware at home cardiovascular test kit | From Baseline to Month 6 | 
| LDL-cholesterol change from Baseline | Fasting LDL-cholesterol is measured using Imaware at home cardiovascular test kit | From Baseline to Month 6 | 
| HDL-cholesterol change from Baseline | Fasting HDL-cholesterol is measured using Imaware at home cardiovascular test kit | From Baseline to Month 6 | 
| hs-CRP change from baseline | hs-CRP is measured using Imaware at home cardiovascular test kit | From Baseline to Month 6 | 
| Fasting glucose | Fasting glucose is measured using Imaware at home cardiovascular test kit | From Baseline to Month 6 | 
| HbA1c change from Baseline | HbA1c is measured using Imaware at home cardiovascular test kit | From Baseline to Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microalgae, Nannochloropsis, AlmegaPL