AlmegaPL CV Health Open Label Study

NCT05267301 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: ALM-CVH-22
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

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.

Conditions

Cholesterol; Triglycerides; Omega-3; Eicosapentaenoic Acid

Keywords

Microalgae; Nannochloropsis; AlmegaPL

Outcome Measures

Primary Outcomes (1)

• Triglyceride change from baseline

  Fasting triglycerides is measured using Imaware at home cardiovascular test kit

  From Baseline to Month 6

Secondary Outcomes (7)

• Total Cholesterol change from baseline

  From Baseline to Month 6

• VLDL-Cholesterol change from Baseline

  From Baseline to Month 6

• LDL-cholesterol change from Baseline

  From Baseline to Month 6

• HDL-cholesterol change from Baseline

  From Baseline to Month 6

• hs-CRP change from baseline

  From Baseline to Month 6

Study Arms (1)

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.

Dietary Supplement: AlmegaPL (FDA NDIN # 826)

Interventions

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.

Also known as: iwi Algal Oil, Nannochloropsis Oil Extract

AlmgaPL

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• New iwi/AlmegaPL subscribers.

You may not qualify if:

• 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

Sponsors & Collaborators

• Qualitas Health: lead
• Arizona State University: collaborator

Study Sites (2)

Arizona State University

Tempe, Arizona, 85281, United States

Location

Qualitas Health

Houston, Texas, 77057, United States

Location

Related Publications (2)

• 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.

  PMID: 32585854 BACKGROUND

• 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.

  PMID: 38379539 DERIVED

Related Links

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

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Self elected consumers who choose to purchase this iwi EPA andiwi Heart product containing 1000-1100 mg of AlmegaPLR

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 4, 2022
• Study Start: May 11, 2022
• Primary Completion: November 14, 2022
• Study Completion: December 1, 2022
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)