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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05267301
Other study ID # ALM-CVH-22
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 11, 2022
Est. completion date December 1, 2022

Study information

Verified date February 2024
Source Qualitas Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 250
Est. completion date December 1, 2022
Est. primary completion date November 14, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Qualitas Health Houston Texas
United States Arizona State University Tempe Arizona

Sponsors (2)

Lead Sponsor Collaborator
Qualitas Health Arizona State University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Triglyceride change from baseline Fasting triglycerides is measured using Imaware at home cardiovascular test kit From Baseline to Month 6
Secondary Total Cholesterol change from baseline Fasting total cholesterol is measured using Imaware at home cardiovascular test kit From Baseline to Month 6
Secondary VLDL-Cholesterol change from Baseline Fasting VLDL-cholesterol is calculated using results from Imaware at home cardiovascular test kit From Baseline to Month 6
Secondary LDL-cholesterol change from Baseline Fasting LDL-cholesterol is measured using Imaware at home cardiovascular test kit From Baseline to Month 6
Secondary HDL-cholesterol change from Baseline Fasting HDL-cholesterol is measured using Imaware at home cardiovascular test kit From Baseline to Month 6
Secondary hs-CRP change from baseline hs-CRP is measured using Imaware at home cardiovascular test kit From Baseline to Month 6
Secondary Fasting glucose Fasting glucose is measured using Imaware at home cardiovascular test kit From Baseline to Month 6
Secondary HbA1c change from Baseline HbA1c is measured using Imaware at home cardiovascular test kit From Baseline to Month 6
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