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CholesterolPhase 4NCT05267301

AlmegaPL CV Health Open Label Study

A Phase 4 study testing AlmegaPL (FDA NDIN # 826) in people with Cholesterol and Triglycerides, run by Qualitas Health at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Cholesterol, Triglycerides, Omega-3
What is being tested?
AlmegaPL (FDA NDIN # 826)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
2 sitesUnited States
Study dates
11 May 2022to 1 Dec 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • New iwi/AlmegaPL subscribers.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Qualitas Health

    Houston, Texas, 77057

  • Arizona State University

    Tempe, Arizona, 85281

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
AlmegaPL (FDA NDIN # 826)
Keywords
Microalgae, Nannochloropsis, AlmegaPL

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlmegaPL (FDA NDIN # 826)Dietary supplement

    Also called iwi Algal Oil, Nannochloropsis Oil Extract

    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.

Study groups in NCT05267301
Study groupRoleWhat they receive
AlmgaPLExperimentalNew 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.
Receives: Dietary Supplement: AlmegaPL (FDA NDIN # 826)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Triglyceride change from baseline

    Fasting triglycerides is measured using Imaware at home cardiovascular test kit

    Measured: From Baseline to Month 6

Secondary outcomes (7)

  1. Total Cholesterol change from baseline

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

    Measured: From Baseline to Month 6

  2. VLDL-Cholesterol change from Baseline

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

    Measured: From Baseline to Month 6

  3. LDL-cholesterol change from Baseline

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

    Measured: From Baseline to Month 6

  4. HDL-cholesterol change from Baseline

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

    Measured: From Baseline to Month 6

  5. hs-CRP change from baseline

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

    Measured: From Baseline to Month 6

  6. Fasting glucose

    Fasting glucose is measured using Imaware at home cardiovascular test kit

    Measured: From Baseline to Month 6

  7. HbA1c change from Baseline

    HbA1c is measured using Imaware at home cardiovascular test kit

    Measured: From Baseline to Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2022
  2. Study start11 May 2022
  3. Primary completion14 Nov 2022
  4. Study completion1 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
Self elected consumers who choose to purchase this iwi EPA andiwi Heart product containing 1000-1100 mg of AlmegaPLR
Masking
None (open label)
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05267301
Sponsor's protocol ID
ALM-CVH-22
Status last verified
Feb 2024
First submitted
23 Feb 2022
Last updated
14 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: All trial data will be shared in an aggregated form, no individual participant data will be used.

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.

    PubMed 32585854

  • 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.

    PubMed 38379539

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing AlmegaPL (FDA NDIN # 826) in people with Cholesterol and Triglycerides, run by Qualitas Health at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Triglyceride change from baseline (time frame: From Baseline to Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05267301, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.

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