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AlmegaPL CV Health Open Label Study

NCT05267301 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2024-02-14

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Arizona State University

    collaborator OTHER

  • Qualitas Health

    lead INDUSTRY

Principal Investigators

  • Eneko Ganuza Taberna, PhD · Qualitas Health

  • Eghogho H Etomi, MSc · Qualitas Health

  • Magdalena Amezquita, MSc · Arizona State University

  • Corrie Whisner, PhD · Arizona State University

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-11
Primary Completion
2022-11-14
Completion
2022-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05267301 on ClinicalTrials.gov