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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
250
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.
Arizona State University
Tempe, Arizona, United States
Qualitas Health
Houston, Texas, United States
Triglyceride change from baseline
Fasting triglycerides is measured using Imaware at home cardiovascular test kit
Time frame: From Baseline to Month 6
Total Cholesterol change from baseline
Fasting total cholesterol is measured using Imaware at home cardiovascular test kit
Time frame: From Baseline to Month 6
VLDL-Cholesterol change from Baseline
Fasting VLDL-cholesterol is calculated using results from Imaware at home cardiovascular test kit
Time frame: From Baseline to Month 6
LDL-cholesterol change from Baseline
Fasting LDL-cholesterol is measured using Imaware at home cardiovascular test kit
Time frame: From Baseline to Month 6
HDL-cholesterol change from Baseline
Fasting HDL-cholesterol is measured using Imaware at home cardiovascular test kit
Time frame: From Baseline to Month 6
hs-CRP change from baseline
hs-CRP is measured using Imaware at home cardiovascular test kit
Time frame: From Baseline to Month 6
Fasting glucose
Fasting glucose is measured using Imaware at home cardiovascular test kit
Time frame: From Baseline to Month 6
HbA1c change from Baseline
HbA1c is measured using Imaware at home cardiovascular test kit
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From Baseline to Month 6