NCT03937206

Evaluation of the Pharmacokinetics, Safety and Effects of NutriterraTM in Healthy Adults

Completed Phase 1, PHASE2 Last updated 23 December 2019

What this trial tests

Phase 1, PHASE2 trial testing NutriterraTM in Healthy in 132 participants. Completed in 13 December 2019.

Timeline

1 May 2019

Primary endpoint
13 December 2019

13 December 2019

Quick facts

Lead sponsor	Nuseed Americas Inc.
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	132
Start date	1 May 2019
Primary completion	13 December 2019
Estimated completion	13 December 2019
Sites	1 location across Canada

Drugs / interventions tested

• NutriterraTM
• Placebo

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Nuseed Americas Inc.

Who can join

Adults 18 to 80, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The blood lipid profile plays a role in health and disease states and is affected by many genetic and lifestyle factors. On the more extreme side, hyperlipidemia (a condition characterized by hypertriglyceridemia, hypercholesteremia, or both) is a risk factor for coronary heart disease (CHD) 1. CHD is the most common form of cardiovascular disease (CVD); it is characterized by arterial obstructions or blockages, and is a leading cause of heart attacks and strokes 2. Specifically, blood lipids including triglycerides (TG), total cholesterol (TC), low density lipoprotein-cholesterol (LDL-C), and the ratio of TC: high density lipoprotein (HDL) cholesterol, are key modifiable risk factors for CHD. Hyperlipidemia is thought to be caused or promoted by sedentary lifestyle, obesity, or uncontrolled type 2 diabetes 2. Therefore, lifestyle factors, like the modification of dietary lipids to maintain a healthy blood lipid profile are warranted.

There are many beneficial effects of omega-3 fatty acids in terms of cardiovascular disease and the nervous system in general, as well as emerging research on DHA supplementation in acute brain and spinal cord injury. Demand for dietary omega-3's, either through increased fish consumption or through DHA supplementation, is expected to increase, particularly as the baby boomer population adds to the ranks of senior citizens concerned about and/or susceptible to health issues such as dementia and Alzheimer's Disease. Availability of EPA and DHA in circulation is an important parameter in understanding biologic properties of fatty acids.

The purpose of this study is to evaluate the pharmacokinetic characteristics of ascending doses of NutriterraTM, as measured by plasma levels of total EPA, DHA, DPA and ALA under fed conditions. In addition, after a two-week (minimum) washout period, subjects will take product for 16 weeks to evaluate effects on cardiovascular markers as a measure of efficacy.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Transgenic Canola Oil Improved Blood Omega-3 Profiles: A Randomized, Placebo-Controlled Trial in Healthy Adults.
   Lin XL, Baisley J, Bier A, Vora D, et al · · 2022 · cited 5× · PMID 35360684 · DOI 10.3389/fnut.2022.847114