AlmegaPL CV Health Open Label Study

Cholesterol Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05267301
• Other study ID #: ALM-CVH-22
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Cholesterol
• Eicosapentaenoic Acid
• Triglycerides

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

External Links

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