Clinical trial NCT05267301: AlmegaPL CV Health Open Label Study
Official title: Open Label Post-market Evaluation of Orally Dosed AlmegaPL on Cholesterol and Cardio-metabolic Parameters.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cholesterol
Triglycerides
Omega-3
Eicosapentaenoic Acid
Keywords: Microalgae
Nannochloropsis
AlmegaPL
Lead sponsor: Qualitas Health
Sponsor class: INDUSTRY
Collaborators: name: Arizona State University
First posted: 2022-03-04
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Self elected consumers who choose to purchase this iwi EPA andiwi Heart product containing 1000-1100 mg of AlmegaPLR
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Triglyceride change from baseline
timeFrame: From Baseline to Month 6
Secondary outcomes:
measure: Total Cholesterol change from baseline
timeFrame: From Baseline to Month 6
measure: VLDL-Cholesterol change from Baseline
timeFrame: From Baseline to Month 6
measure: LDL-cholesterol change from Baseline
timeFrame: From Baseline to Month 6
measure: HDL-cholesterol change from Baseline
timeFrame: From Baseline to Month 6
measure: hs-CRP change from baseline
timeFrame: From Baseline to Month 6
measure: Fasting glucose
timeFrame: From Baseline to Month 6
measure: HbA1c change from Baseline
timeFrame: From Baseline to Month 6
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Arizona State University
state: Arizona
city: Houston
country: United States
facility: Qualitas Health
state: Texas
Study officials:
affiliation: Qualitas Health
name: Eneko Ganuza Taberna, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Qualitas Health
name: Eghogho H Etomi, MSc
role: STUDY_DIRECTOR
affiliation: Arizona State University
name: Magdalena Amezquita, MSc
role: STUDY_DIRECTOR
affiliation: Arizona State University
name: Corrie Whisner, PhD
role: STUDY_CHAIR
References:
citation: 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.