Effect of Dose of Buglossoides Oil on EPA Accrual and on the Inflammatory Response

Study of the Effect of Dose of Buglossoides Arvensis Oil on Eicosapentaenoic Acid Accrual and on the Inflammatory Response

The effect of various doses of Buglossoides oil on the accrual of eicosapentaenoic acid (EPA) in blood and circulating cells will be investigated.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: High Oleic Sunflower Oil; Dietary supplement: Buglossoides oil

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1A 3E9
      • Universite de Moncton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Men or non-pregnant women, using an effective form of birth control (such as oral contraceptives, injectable contraceptives or the barrier method such as a intrauterine device (IUD) with a spermicide, a diaphragm with a spermicide, a condom with a spermicide or a sponge with a spermicide) for at least 3 months prior to entry into the study and continuing during participation in the study.
2. 18 to 65 years of age, inclusive.
3. Body mass index (BMI) 18 - 39.9 kg/m2
4. Subject is willing to avoid alcohol consumption for 24h prior to every clinic visit.
5. The subject will not modify smoking habits during supplementation period.
6. No significant medical conditions that in the opinion of the qualified physician, would preclude the subject's participation in the study.
7. Signed informed consent.
8. Willing to follow all study procedures including study visits, fasting blood draws, stable body weight, normal eating habits, current activity level, and compliance with study preparation.
9. Willing to not consume fish, crustaceans and shellfish for the duration of the study.

Exclusion Criteria:

1. Pregnancy or lactation. Women trying to conceive. Women who will try to conceive who are unwilling to commit to the use of a medically approved form of contraception throughout the study period. Method of contraception must be recorded in the case report file.
2. Individual has a condition the study physician believes would interfere with the participant's ability to provide informed consent, comply with his responsibilities during the study, which might confound the interpretation of the study results or put the person at undue risk.
3. Medical conditions including an active peptic ulcer, inflammatory bowel disease, or gastrointestinal bleeding and any medical condition or prior gastrointestinal surgery that could influence absorption, metabolism or excretion of the study supplement.
4. History or presence of significant, renal, hepatic, gastrointestinal, pulmonary, biliary, neurological or endocrine disorders.
5. History or presence of cancer in the past 2 yrs, except for non-melanoma skin cancers (e.g. basal or squamous cell carcinoma of the skin).
6. Clinically significant abnormal laboratory test results including but not limited to LDL-cholesterol ≥ 4.1mM, triglyceride levels ≥3.95mM, fasting creatinine ≥ 1.5 mg/dL, alanine transaminase or aspartate aminotransferase ≥ 1.5X the upper limit of normal.
7. Currently being treated for angina, arrhythmia and/or congestive heart failure. History of myocardial infarction or stroke.
8. Uncontrolled hypertension (resting systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg).
9. Type 1 or 2 diabetes. Fasting glucose ≥ 100 mg/dL. HbA1c ≥ 6.0.
10. If a smoker, subject smokes no more than 1 pack (20 cigarettes) daily.
11. History (within 12 months) or current alcohol or substance abuse (no more than 14 consumptions per week; 1 consumption= 12 oz beer, 5 oz wine, 1.5 oz distilled spirits).
12. Use of any lipid-altering medications (statins, bile acid sequestrants, cholesterol absorption inhibitors, fibrates, over the counter and prescription formulations of niacin).
13. Unstable use of thyroid medication. Stable, treated hypothyroidism is not an exclusion criteria.
14. Use of any weight loss or lipid metabolism medication/supplement/program (including lipase inhibitors) within 1 month of study period OR weight gain or loss > 2 kg in the past 3 months.
15. Currently taking fish oil or any other omega-3 or omega-6 polyunsaturated fatty acids (PUFA) supplement/drug within one month of Visit 1 and throughout the study. Consumption of fatty fish (salmon, herring, mackerel, albacore tuna, and sardines) more than 2X a month within one month of visit 1 and throughout the study period. Consumption (more than twice a month) of any EPA/DHA enriched foods (e.g. docosahexaenoic acid (DHA)-enriched eggs) within one month of Visit 1. Unwillingness to avoid all fish including shellfish and crustaceans throughout the study period.
16. Use of alpha-linolenic acid-containing seeds and oils such as flax seed, chia seed, perilla seed, hemp, spirulina, walnut, mustard seed or black currant seeds/oil within one month of Visit 1 and throughout the study.
17. Use of an investigational product within the previous 30 days.
18. Has donated blood up to 4 weeks before the start of the study. Not willing to cease being a blood donor during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: High oleic sunflower oil (HOSO); 10 ml HOSO/day in a single dose, 28 days	Dietary supplement: High Oleic Sunflower Oil; Other Names: HOSO
Experimental: High dose Buglossoides oil; 10 ml Buglossoides oil/day in a single dose, 28 days	Dietary supplement: Buglossoides oil; Other Names: Ahiflower
Experimental: Medium dose Buglossoides oil; 6 ml Buglossoides oil + 4 ml HOSO/day in a single dose, 28 days	Dietary supplement: High Oleic Sunflower Oil; Other Names: HOSO; Dietary supplement: Buglossoides oil; Other Names: Ahiflower
Experimental: Low dose Buglossoides oil; 3 ml Buglossoides oil + 7 ml HOSO/day in a single dose, 28 days	Dietary supplement: High Oleic Sunflower Oil; Other Names: HOSO; Dietary supplement: Buglossoides oil; Other Names: Ahiflower

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma eicosapentaenoic concentration (EPA)	Expressed as μmol/L plasma	Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma 20:4n-3	Expressed as μmol/L plasma	Day 28
Plasma docosapentaenoic acid (DPA)	Expressed as μmol/L plasma	Day 28
Plasma 20:4n-3, EPA and DPA individually as % of total fatty acids		Day 28
Mononuclear cell 20:4n-3, EPA and DPA individually as % of total fatty acids		Day 28
Fasting serum chemistry: glucose		Day 28
Fasting serum chemistry: calcium		Day 28
Fasting serum chemistry: sodium		Day 28
Fasting serum chemistry: potassium		Day 28
Fasting serum chemistry: blood urea nitrogen		Day 28
Fasting serum chemistry: creatinine		Day 28
Fasting serum chemistry: alkaline phosphatase		Day 28
Fasting serum chemistry: aspartate aminotransferase		Day 28
Fasting serum chemistry: gamma-glutamyltransferase		Day 28
Fasting serum chemistry: total bilirubin		Day 28
Fasting serum chemistry: amylase		Day 28
Fasting serum chemistry: uric acid		Day 28
Fasting serum chemistry: albumin		Day 28
Fasting hematology: white blood cell count		Day 28
Fasting hematology: neutrophil count		Day 28
Fasting hematology: red blood cell count		Day 28
Fasting hematology:hemoglobin		Day 28
Fasting hematology: hematocrit		Day 28
Fasting hematology: platelet count		Day 28
Fasting blood lipid profile: triglycerides		Day 28
Fasting blood lipid profile: total cholesterol		Day 28
Fasting blood lipid profile: low density lipoprotein cholesterol (LDL-c)		Day 28
Fasting blood lipid profile: non-high density lipoprotein-cholesterol (non-HDL-c)		Day 28
Fasting blood lipid profile: HDL-c		Day 28
Fasting serum chemistry: chloride		Day 28
Estimated glomerular filtration rate		Day 28
Fasting hematology profile: mean corpuscular volume		Day 28
Fasting hematology profile: mean corpuscular hemoglobin		Day 28
Fasting hematology profile: mean corpuscular hemoglobin concentration		Day 28
Fasting hematology profile: red cell distribution width		Day 28
Fasting hematology profile: mean platelet volume		Day 28
Fasting hematology profile: lymphocyte concentration		Day 28
Fasting hematology profile: monocyte count		Day 28
Fasting hematology profile: eosinophil count		Day 28
Fasting hematology profile: basophil count		Day 28
Fasting hematology profile: Immature granulocytes count		Day 28
Fasting hematology profile: immature granulocytes (% white blood cell (WBC))		Day 28
Fasting hematology profile: neutrophil (% WBC)		Day 28
Fasting hematology profile: lymphocyte (% WBC)		Day 28
Fasting hematology profile: monocytes (% WBC)		Day 28
Fasting hematology profile: eosinophil (% WBC)		Day 28
Fasting hematology profile: basophil (% WBC)		Day 28
Urinalysis: appearance		Day 28
Urinalysis: density		Day 28
Urinalysis: leukocyte esterase		Day 28
Urinalysis: nitrites		Day 28
Urinalysis: pH		Day 28
Urinalysis: protein		Day 28
Urinalysis: glucose		Day 28
Urinalysis: acetone		Day 28
Urinalysis: blood		Day 28
Urinalysis: urobilinogen		Day 28

Other Outcome Measures

Outcome Measure	Time Frame
Cytokine production following ex vivo stimulation: interferon-gamma	Day 28
Cytokine production following ex vivo stimulation: interleukin-1beta	Day 28
Cytokine production following ex vivo stimulation: interleukin-6	Day 28
Cytokine production following ex vivo stimulation: interleukin-8	Day 28
Cytokine production following ex vivo stimulation: interleukin-10	Day 28
Cytokine production following ex vivo stimulation: interleukin-17A	Day 28
Cytokine production following ex vivo stimulation: interleukin-23	Day 28
Cytokine production following ex vivo stimulation: monocyte chemoattractant protein-1	Day 28
Cytokine production following ex vivo stimulation: tumor necrosis factor-alpha	Day 28

Collaborators and Investigators

• Sponsor: Réseau de Santé Vitalité Health Network

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: August 24, 2015
• First Submitted That Met QC Criteria: September 1, 2015
• First Posted (Estimate): September 4, 2015

Study Record Updates

• Last Update Posted (Estimate): March 11, 2016
• Last Update Submitted That Met QC Criteria: March 10, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: omega-3 fatty acids; participants; Buglossoides arvensis; vegetable oil
• Other Study ID Numbers: HC-NNHPD-213421