AlmegaPL CV Health Open Label Study

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

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.

Study Overview

• Status: Completed
• Conditions: Triglycerides; Cholesterol; Eicosapentaenoic Acid; Omega-3
• Intervention / Treatment: Dietary supplement: AlmegaPL (FDA NDIN # 826)

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.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85281
      • Arizona State University
  • Texas
    • Houston, Texas, United States, 77057
      • Qualitas Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: AlmgaPL; 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 (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.; Other Names: iwi Algal Oil; Nannochloropsis Oil Extract

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Qualitas Health
• Collaborators: Arizona State University
• Investigators: Principal Investigator: Eneko Ganuza Taberna, PhD, Qualitas Health; Study Director: Eghogho H Etomi, MSc, Qualitas Health; Study Director: Magdalena Amezquita, MSc, Arizona State University; Study Chair: Corrie Whisner, PhD, Arizona State University

Publications and helpful links

General Publications

• 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.

Helpful Links

• Online shop where new subscriptions are identified
• At home heart health test kit web portal
• Peer reviewed article frontiers in nutrition

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2022
• Primary Completion (Actual): November 14, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: February 23, 2022
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Microalgae; Nannochloropsis; AlmegaPL
• Other Study ID Numbers: ALM-CVH-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All trial data will be shared in an aggregated form, no individual participant data will be used.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No