Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Arizona State University | OTHER |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AlmgaPL | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AlmegaPL (FDA NDIN # 826) | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Triglyceride change from baseline | Fasting triglycerides is measured using Imaware at home cardiovascular test kit | From Baseline to Month 6 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eneko Ganuza Taberna, PhD | Qualitas Health | Principal Investigator |
| Eghogho H Etomi, MSc | Qualitas Health | Study Director |
| Magdalena Amezquita, MSc | Arizona State University | Study Director |
| Corrie Whisner, PhD | Arizona State University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona State University | Tempe | Arizona | 85281 | United States | ||
| Qualitas Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32585854 | Background | Rao A, Briskey D, Nalley JO, Ganuza E. Omega-3 Eicosapentaenoic Acid (EPA) Rich Extract from the Microalga Nannochloropsis Decreases Cholesterol in Healthy Individuals: A Double-Blind, Randomized, Placebo-Controlled, Three-Month Supplementation Study. Nutrients. 2020 Jun 23;12(6):1869. doi: 10.3390/nu12061869. | |
| 38379539 | Derived |
| Label | URL |
|---|---|
| Online shop where new subscriptions are identified | View source |
Not provided
All trial data will be shared in an aggregated form, no individual participant data will be used.
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 4, 2022 | Nov 14, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 4, 2022 | Nov 14, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 7, 2022 | Nov 14, 2022 | ICF_002.pdf |
Not provided
Self elected consumers who choose to purchase this iwi EPA andiwi Heart product containing 1000-1100 mg of AlmegaPLR
Not provided
Not provided
Not provided
Not provided
|
|
| 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 |
| Houston |
| Texas |
| 77057 |
| United States |
| Ganuza E, Etomi EH, Olson M, Whisner CM. Omega-3 eicosapentaenoic polar-lipid rich extract from microalgae Nannochloropsis decreases plasma triglycerides and cholesterol in a real-world normolipidemic supplement consumer population. Front Nutr. 2024 Feb 6;11:1293909. doi: 10.3389/fnut.2024.1293909. eCollection 2024. |
| At home heart health test kit web portal | View source |
| Peer reviewed article frontiers in nutrition | View source |