Cholesterol, Eicosapentaenoic Acid, Omega-3, Triglycerides
Conditions
Keywords
Microalgae, Nannochloropsis, AlmegaPL
Brief 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.
Interventions
DIETARY_SUPPLEMENTAlmegaPL (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.
Sponsors
Arizona State University
Qualitas Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Self elected consumers who choose to purchase this iwi EPA andiwi Heart product containing 1000-1100 mg of AlmegaPLR
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Triglyceride change from baseline | From Baseline to Month 6 | Fasting triglycerides is measured using Imaware at home cardiovascular test kit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VLDL-Cholesterol change from Baseline | From Baseline to Month 6 | Fasting VLDL-cholesterol is calculated using results from Imaware at home cardiovascular test kit |
| LDL-cholesterol change from Baseline | From Baseline to Month 6 | Fasting LDL-cholesterol is measured using Imaware at home cardiovascular test kit |
| HDL-cholesterol change from Baseline | From Baseline to Month 6 | Fasting HDL-cholesterol is measured using Imaware at home cardiovascular test kit |
| Total Cholesterol change from baseline | From Baseline to Month 6 | Fasting total cholesterol is measured using Imaware at home cardiovascular test kit |
| Fasting glucose | From Baseline to Month 6 | Fasting glucose is measured using Imaware at home cardiovascular test kit |
| HbA1c change from Baseline | From Baseline to Month 6 | HbA1c is measured using Imaware at home cardiovascular test kit |
| hs-CRP change from baseline | From Baseline to Month 6 | hs-CRP is measured using Imaware at home cardiovascular test kit |
Countries
United States
Outcome results
None listed