Clinical trial NCT03937206: Evaluation of the Pharmacokinetics, Safety and Effects of NutriterraTM in Healthy Adults
Official title: A Randomized, Double-Blind, Placebo-Controlled Dose Ranging Study to Evaluate the Pharmacokinetics, Safety and Effects of NutriterraTM in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Lead sponsor: Nuseed Americas Inc.
Sponsor class: INDUSTRY
Collaborators: name: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
First posted: 2019-05-03
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Adults 18 years to 80 years (inclusive) at time of screening with suitable veins for cannulation or repeated venipuncture.
* BMI ≥ 18.5 to ≤ 34.9 kg/m2 at the time of Screening
* Female participants of childbearing potential (i.e. not surgically sterilized or post-menopausal greater than one year) must have negative urine pregnancy test and must be using an effective birth control method, defined as:

  * Continuous use of oral or long acting injected contraceptive for at least 2 months prior to study entry, or
  * Use of an intra-uterine device or implantable contraceptive, or
  * Use of double barrier methods of birth control, or
  * Abstinence from heterosexual intercourse
* Willing to avoid alcohol consumption for 24 h prior to every clinic visit
* Willing to avoid moderate to intense exercise 24 h prior to every clinic visit
* Consume less than 200 mg omega-3 per day based on validated Questionnaire
* Agrees to stop taking any vitamins, minerals, or any fatty acid containing dietary/herbal supplements that could potentially interfere with the study endpoints and will be washed out for two weeks prior to study product administration and throughout the study.
* Willing to maintain a stable diet and level of activity throughout the trial.
* Willing to keep a daily journal describing impact of dosage and tolerability.
* Able to comply with all protocol activities.
* Willing and able to provide informed written consent.

Exclusion Criteria:

* Consumption of fish within two weeks prior to the first investigational product administration and for the duration of the study.
* Used canola oil, fish oil, other omega-3 fatty acids (EPA and/or DHA) containing supplements within one (1) month of baseline (Visit 2) or any time during the study, other than the product being evaluated in this study.
* Have a known sensitivity or allergy to canola or any other ingredients in the test products.
* Individuals taking prescription or non-prescription health products that may affect the study endpoint (e.g. corticosteroids, prescription anti-inflammatory drugs, blood lipid-lowering drugs (e.g. statins, fibrates, bile acid exchanger resin, phytosterols, niacin or its analogues, carnitine, etc.) in the previous 6 months.
* Individuals taking any supplements with phytosterols, polyglucosamines (Chitosan) or other lipid-binding ingredients in the previous 3 months.
* Unstable use (i.e. initiation or change in dose) of antihypertensive medications or thyroid hormone replacement medications within 3 months prior to visit 1.
* Use of any weight-loss programs or weight-loss medications (prescription or over-the counter) including, but not limited to, lipase inhibitors, within 6 months prior to visit 1 and throughout the study.
* Pregnancy or lactation, or participant unwilling to take appropriate contraceptives for the duration of the study.
* History of blood clotting disorders or use of coagulation-inhibiting drugs (e.g. warfarin).
* History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs (i.e. Crohn's disease, short bowel, acute or chronic pancreatitis or pancreatic insufficiency).
* Presence of major diseases such as diabetes, endocrine, cardiovascular, renal, or liver disease.
* History of neurological disease (e.g. Parkinson's disease, stroke, traumatic brain injury, etc.).
* History of cancer (excluding non-melanoma skin cancer and basal cell carcinoma) in the past 5 years.
* Uncontrolled hypertension defined as a seated resting systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg.
* Active psychiatric disease (hospitalized within the past 12 months of Screening).
* Documented medical history of immune disorder (such as HIV/aids, hepatitis B or hepatitis C) or positive laboratory results within 28 days of dosing.
* History of a surgical procedure for the treatment of obesity (i.e., gastric bypass, gastric banding).
* Taking potent CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin and nefazodone) within two weeks prior to first investigational product administration and throughout the study.

Primary outcomes:
measure: EPA Area Under the Curve
timeFrame: 72 hours
measure: DHA Area Under the Curve
timeFrame: 72 hours
measure: Triglycerides
timeFrame: 16 weeks
Secondary outcomes:
measure: Total Cholesterol
timeFrame: 16 weeks
measure: HDL-C
timeFrame: 16 weeks
measure: LDL-C
timeFrame: 16 weeks
measure: LDL-C/HDL-C ratio
timeFrame: 16 weeks
measure: non-HDL-C
timeFrame: 16 weeks
measure: Omega-3 fatty acid profile in whole blood
timeFrame: 4 weeks
measure: Omega-3 fatty acid profile in red blood cells
timeFrame: 16 weeks
measure: C-reactive protein
timeFrame: 4 and 16 weeks
Other outcomes:
Locations:
city: Guelph
country: Canada
facility: Nutrasource
state: Ontario
Study officials:
References: