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OpenTrials
Completed

NCT Number: NCT05267301

AlmegaPL CV Health Open Label Study

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.

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Key information

Conditions

Cholesterol Eicosapentaenoic Acid Omega-3 Triglycerides

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Arizona State University, Tempe, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: iwi Algal Oil, Nannochloropsis Oil Extract

Primary outcomes

  1. Triglyceride change from baseline

    Time frame: From Baseline to Month 6

    Fasting triglycerides is measured using Imaware at home cardiovascular test kit

Secondary outcomes

  1. Total Cholesterol change from baseline

    Time frame: From Baseline to Month 6

    Fasting total cholesterol is measured using Imaware at home cardiovascular test kit

  2. VLDL-Cholesterol change from Baseline

    Time frame: From Baseline to Month 6

    Fasting VLDL-cholesterol is calculated using results from Imaware at home cardiovascular test kit

  3. LDL-cholesterol change from Baseline

    Time frame: From Baseline to Month 6

    Fasting LDL-cholesterol is measured using Imaware at home cardiovascular test kit

  4. HDL-cholesterol change from Baseline

    Time frame: From Baseline to Month 6

    Fasting HDL-cholesterol is measured using Imaware at home cardiovascular test kit

  5. hs-CRP change from baseline

    Time frame: From Baseline to Month 6

    hs-CRP is measured using Imaware at home cardiovascular test kit

  6. Fasting glucose

    Time frame: From Baseline to Month 6

    Fasting glucose is measured using Imaware at home cardiovascular test kit

  7. HbA1c change from Baseline

    Time frame: From Baseline to Month 6

    HbA1c is measured using Imaware at home cardiovascular test kit

Sponsors and collaborators

Lead sponsor

Qualitas Health

Industry

Collaborators

  • Arizona State University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 4, 2022
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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