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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03937206
Recruitment Status : Completed
First Posted : May 3, 2019
Last Update Posted : December 23, 2019
Sponsor:
Collaborator:
Nutrasource Diagnostics Inc.
Information provided by (Responsible Party):
Nuseed Americas Inc.

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.


Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: NutriterraTM Dietary Supplement: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blind, Placebo-Controlled Dose Ranging Study to Evaluate the Pharmacokinetics, Safety and Effects of NutriterraTM in Healthy Adult Subjects
Actual Study Start Date : May 1, 2019
Actual Primary Completion Date : December 13, 2019
Actual Study Completion Date : December 13, 2019

Arm Intervention/treatment
Experimental: Low Dose
Low Dose (300mg TG Omega-3) - 1 capsule containing 1000mg NutriterraTM per capsule + 3 capsules containing 1000mg corn oil per capsule
Dietary Supplement: NutriterraTM
Nutriterra 1000mg
Other Name: Canola Oil

Dietary Supplement: Placebo
Corn Oil 1000mg

Experimental: Mid Dose
Mid Dose (600mg TG Omega-3) - 2 capsules containing 1000mg NutriterraTM per capsule + 2 capsules containing 1000mg corn oil per capsule
Dietary Supplement: NutriterraTM
Nutriterra 1000mg
Other Name: Canola Oil

Dietary Supplement: Placebo
Corn Oil 1000mg

Experimental: High Dose
High Dose (1200mg TG Omega-3) - 4 capsules containing 1000mg NutriterraTM per capsule
Dietary Supplement: NutriterraTM
Nutriterra 1000mg
Other Name: Canola Oil

Placebo Comparator: Placebo
Placebo (0mg TG Omega-3) - 4 capsules containing 1000mg corn oil per capsule
Dietary Supplement: Placebo
Corn Oil 1000mg




Primary Outcome Measures :
  1. EPA Area Under the Curve [ Time Frame: 72 hours ]
    To determine the pharmacokinetics over a 72-hour period of NutriterraTM at three doses under fed conditions in healthy subjects

  2. DHA Area Under the Curve [ Time Frame: 72 hours ]
    To determine the pharmacokinetics over a 72-hour period of NutriterraTM at three doses under fed conditions in healthy subjects

  3. Triglycerides [ Time Frame: 16 weeks ]
    To evaluate the dose response and effect of NutriterraTM on triglyceride (TG) levels in healthy subjects


Secondary Outcome Measures :
  1. Total Cholesterol [ Time Frame: 16 weeks ]
    To determine the effect of daily use of NutriterraTM on total cholesterol

  2. HDL-C [ Time Frame: 16 weeks ]
    To determine the effect of daily use of NutriterraTM on HDL-C

  3. LDL-C [ Time Frame: 16 weeks ]
    To determine the effect of daily use of NutriterraTM on LDL-C

  4. LDL-C/HDL-C ratio [ Time Frame: 16 weeks ]
    To determine the effect of daily use of NutriterraTM on LDL-C/HDL-C ratio

  5. non-HDL-C [ Time Frame: 16 weeks ]
    To determine the effect of daily use of NutriterraTM on non-HDL-C

  6. Omega-3 fatty acid profile in whole blood [ Time Frame: 4 weeks ]
    To determine the effect of daily use of NutriterraTM on whole blood omega-3 fatty acid profile

  7. Omega-3 fatty acid profile in red blood cells [ Time Frame: 16 weeks ]
    To determine the effect of daily use of NutriterraTM on red blood cell omega-3 fatty acid profile

  8. C-reactive protein [ Time Frame: 4 and 16 weeks ]
    To determine the effect of daily use of NutriterraTM on high sensitivity C-reactive protein (hs-CRP)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937206


Locations
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Canada, Ontario
Nutrasource
Guelph, Ontario, Canada, N1G 0B4
Sponsors and Collaborators
Nuseed Americas Inc.
Nutrasource Diagnostics Inc.
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Responsible Party: Nuseed Americas Inc.
ClinicalTrials.gov Identifier: NCT03937206    
Other Study ID Numbers: NUSERPD-160001-RPD01
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No