Clinical trial NCT02540759: Effect of Dose of Buglossoides Oil on EPA Accrual and on the Inflammatory Response
Official title: Study of the Effect of Dose of Buglossoides Arvensis Oil on Eicosapentaenoic Acid Accrual and on the Inflammatory Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Buglossoides arvensis
vegetable oil
omega-3 fatty acids
participants
Lead sponsor: Réseau de Santé Vitalité Health Network
Sponsor class: OTHER
First posted: 2015-09-04
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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.

Primary outcomes:
measure: Plasma eicosapentaenoic concentration (EPA)
timeFrame: Day 28
Secondary outcomes:
measure: Plasma 20:4n-3
timeFrame: Day 28
measure: Plasma docosapentaenoic acid (DPA)
timeFrame: Day 28
measure: Plasma 20:4n-3, EPA and DPA individually as % of total fatty acids
timeFrame: Day 28
measure: Mononuclear cell 20:4n-3, EPA and DPA individually as % of total fatty acids
timeFrame: Day 28
measure: Fasting serum chemistry: glucose
timeFrame: Day 28
measure: Fasting serum chemistry: calcium
timeFrame: Day 28
measure: Fasting serum chemistry: sodium
timeFrame: Day 28
measure: Fasting serum chemistry: potassium
timeFrame: Day 28
measure: Fasting serum chemistry: blood urea nitrogen
timeFrame: Day 28
measure: Fasting serum chemistry: creatinine
timeFrame: Day 28
measure: Fasting serum chemistry: alkaline phosphatase
timeFrame: Day 28
measure: Fasting serum chemistry: aspartate aminotransferase
timeFrame: Day 28
measure: Fasting serum chemistry: gamma-glutamyltransferase
timeFrame: Day 28
measure: Fasting serum chemistry: total bilirubin
timeFrame: Day 28
measure: Fasting serum chemistry: amylase
timeFrame: Day 28
measure: Fasting serum chemistry: uric acid
timeFrame: Day 28
measure: Fasting serum chemistry: albumin
timeFrame: Day 28
measure: Fasting hematology: white blood cell count
timeFrame: Day 28
measure: Fasting hematology: neutrophil count
timeFrame: Day 28
measure: Fasting hematology: red blood cell count
timeFrame: Day 28
measure: Fasting hematology:hemoglobin
timeFrame: Day 28
measure: Fasting hematology: hematocrit
timeFrame: Day 28
measure: Fasting hematology: platelet count
timeFrame: Day 28
measure: Fasting blood lipid profile: triglycerides
timeFrame: Day 28
measure: Fasting blood lipid profile: total cholesterol
timeFrame: Day 28
measure: Fasting blood lipid profile: low density lipoprotein cholesterol (LDL-c)
timeFrame: Day 28
measure: Fasting blood lipid profile: non-high density lipoprotein-cholesterol (non-HDL-c)
timeFrame: Day 28
measure: Fasting blood lipid profile: HDL-c
timeFrame: Day 28
measure: Fasting serum chemistry: chloride
timeFrame: Day 28
measure: Estimated glomerular filtration rate
timeFrame: Day 28
measure: Fasting hematology profile: mean corpuscular volume
timeFrame: Day 28
measure: Fasting hematology profile: mean corpuscular hemoglobin
timeFrame: Day 28
measure: Fasting hematology profile: mean corpuscular hemoglobin concentration
timeFrame: Day 28
measure: Fasting hematology profile: red cell distribution width
timeFrame: Day 28
measure: Fasting hematology profile: mean platelet volume
timeFrame: Day 28
measure: Fasting hematology profile: lymphocyte concentration
timeFrame: Day 28
measure: Fasting hematology profile: monocyte count
timeFrame: Day 28
measure: Fasting hematology profile: eosinophil count
timeFrame: Day 28
measure: Fasting hematology profile: basophil count
timeFrame: Day 28
measure: Fasting hematology profile: Immature granulocytes count
timeFrame: Day 28
measure: Fasting hematology profile: immature granulocytes (% white blood cell (WBC))
timeFrame: Day 28
measure: Fasting hematology profile: neutrophil (% WBC)
timeFrame: Day 28
measure: Fasting hematology profile: lymphocyte (% WBC)
timeFrame: Day 28
measure: Fasting hematology profile: monocytes (% WBC)
timeFrame: Day 28
measure: Fasting hematology profile: eosinophil (% WBC)
timeFrame: Day 28
measure: Fasting hematology profile: basophil (% WBC)
timeFrame: Day 28
measure: Urinalysis: appearance
timeFrame: Day 28
measure: Urinalysis: density
timeFrame: Day 28
measure: Urinalysis: leukocyte esterase
timeFrame: Day 28
measure: Urinalysis: nitrites
timeFrame: Day 28
measure: Urinalysis: pH
timeFrame: Day 28
measure: Urinalysis: protein
timeFrame: Day 28
measure: Urinalysis: glucose
timeFrame: Day 28
measure: Urinalysis: acetone
timeFrame: Day 28
measure: Urinalysis: blood
timeFrame: Day 28
measure: Urinalysis: urobilinogen
timeFrame: Day 28
Other outcomes:
measure: Cytokine production following ex vivo stimulation: interferon-gamma
timeFrame: Day 28
measure: Cytokine production following ex vivo stimulation: interleukin-1beta
timeFrame: Day 28
measure: Cytokine production following ex vivo stimulation: interleukin-6
timeFrame: Day 28
measure: Cytokine production following ex vivo stimulation: interleukin-8
timeFrame: Day 28
measure: Cytokine production following ex vivo stimulation: interleukin-10
timeFrame: Day 28
measure: Cytokine production following ex vivo stimulation: interleukin-17A
timeFrame: Day 28
measure: Cytokine production following ex vivo stimulation: interleukin-23
timeFrame: Day 28
measure: Cytokine production following ex vivo stimulation: monocyte chemoattractant protein-1
timeFrame: Day 28
measure: Cytokine production following ex vivo stimulation: tumor necrosis factor-alpha
timeFrame: Day 28
Locations:
city: Moncton
country: Canada
facility: Université de Moncton
state: New Brunswick
Study officials:
affiliation: Université de Moncton, Moncton, NB, Canada
name: Marc Surette, PhD
role: PRINCIPAL_INVESTIGATOR
References: