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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02540759
• Other study ID #: HC-NNHPD-213421
• Status: Completed
• Phase: Phase 1
• First received: August 24, 2015
• Last updated: March 10, 2016
• Start date: September 2015
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Réseau de Santé Vitalité Health Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Non-prescription and Natural Health Products Directorate
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Buglossoides oil

• High Oleic Sunflower Oil

Locations

Country	Name	City	State
Canada	Université de Moncton	Moncton	New Brunswick

Sponsors (1)

Lead Sponsor	Collaborator
Réseau de Santé Vitalité Health Network

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cytokine production following ex vivo stimulation: interferon-gamma		Day 28	No
Other	Cytokine production following ex vivo stimulation: interleukin-1beta		Day 28	No
Other	Cytokine production following ex vivo stimulation: interleukin-6		Day 28	No
Other	Cytokine production following ex vivo stimulation: interleukin-8		Day 28	No
Other	Cytokine production following ex vivo stimulation: interleukin-10		Day 28	No
Other	Cytokine production following ex vivo stimulation: interleukin-17A		Day 28	No
Other	Cytokine production following ex vivo stimulation: interleukin-23		Day 28	No
Other	Cytokine production following ex vivo stimulation: monocyte chemoattractant protein-1		Day 28	No
Other	Cytokine production following ex vivo stimulation: tumor necrosis factor-alpha		Day 28	No
Primary	Plasma eicosapentaenoic concentration (EPA)	Expressed as µmol/L plasma	Day 28	No
Secondary	Plasma 20:4n-3	Expressed as µmol/L plasma	Day 28	No
Secondary	Plasma docosapentaenoic acid (DPA)	Expressed as µmol/L plasma	Day 28	No
Secondary	Plasma 20:4n-3, EPA and DPA individually as % of total fatty acids		Day 28	No
Secondary	Mononuclear cell 20:4n-3, EPA and DPA individually as % of total fatty acids		Day 28	No
Secondary	Fasting serum chemistry: glucose		Day 28	Yes
Secondary	Fasting serum chemistry: calcium		Day 28	Yes
Secondary	Fasting serum chemistry: sodium		Day 28	Yes
Secondary	Fasting serum chemistry: potassium		Day 28	Yes
Secondary	Fasting serum chemistry: blood urea nitrogen		Day 28	Yes
Secondary	Fasting serum chemistry: creatinine		Day 28	Yes
Secondary	Fasting serum chemistry: alkaline phosphatase		Day 28	Yes
Secondary	Fasting serum chemistry: aspartate aminotransferase		Day 28	Yes
Secondary	Fasting serum chemistry: gamma-glutamyltransferase		Day 28	Yes
Secondary	Fasting serum chemistry: total bilirubin		Day 28	Yes
Secondary	Fasting serum chemistry: amylase		Day 28	Yes
Secondary	Fasting serum chemistry: uric acid		Day 28	Yes
Secondary	Fasting serum chemistry: albumin		Day 28	Yes
Secondary	Fasting hematology: white blood cell count		Day 28	Yes
Secondary	Fasting hematology: neutrophil count		Day 28	Yes
Secondary	Fasting hematology: red blood cell count		Day 28	Yes
Secondary	Fasting hematology:hemoglobin		Day 28	Yes
Secondary	Fasting hematology: hematocrit		Day 28	Yes
Secondary	Fasting hematology: platelet count		Day 28	Yes
Secondary	Fasting blood lipid profile: triglycerides		Day 28	Yes
Secondary	Fasting blood lipid profile: total cholesterol		Day 28	Yes
Secondary	Fasting blood lipid profile: low density lipoprotein cholesterol (LDL-c)		Day 28	Yes
Secondary	Fasting blood lipid profile: non-high density lipoprotein-cholesterol (non-HDL-c)		Day 28	Yes
Secondary	Fasting blood lipid profile: HDL-c		Day 28	Yes
Secondary	Fasting serum chemistry: chloride		Day 28	Yes
Secondary	Estimated glomerular filtration rate		Day 28	Yes
Secondary	Fasting hematology profile: mean corpuscular volume		Day 28	Yes
Secondary	Fasting hematology profile: mean corpuscular hemoglobin		Day 28	Yes
Secondary	Fasting hematology profile: mean corpuscular hemoglobin concentration		Day 28	Yes
Secondary	Fasting hematology profile: red cell distribution width		Day 28	Yes
Secondary	Fasting hematology profile: mean platelet volume		Day 28	Yes
Secondary	Fasting hematology profile: lymphocyte concentration		Day 28	Yes
Secondary	Fasting hematology profile: monocyte count		Day 28	Yes
Secondary	Fasting hematology profile: eosinophil count		Day 28	Yes
Secondary	Fasting hematology profile: basophil count		Day 28	Yes
Secondary	Fasting hematology profile: Immature granulocytes count		Day 28	Yes
Secondary	Fasting hematology profile: immature granulocytes (% white blood cell (WBC))		Day 28	Yes
Secondary	Fasting hematology profile: neutrophil (% WBC)		Day 28	Yes
Secondary	Fasting hematology profile: lymphocyte (% WBC)		Day 28	Yes
Secondary	Fasting hematology profile: monocytes (% WBC)		Day 28	Yes
Secondary	Fasting hematology profile: eosinophil (% WBC)		Day 28	Yes
Secondary	Fasting hematology profile: basophil (% WBC)		Day 28	Yes
Secondary	Urinalysis: appearance		Day 28	Yes
Secondary	Urinalysis: density		Day 28	Yes
Secondary	Urinalysis: leukocyte esterase		Day 28	Yes
Secondary	Urinalysis: nitrites		Day 28	Yes
Secondary	Urinalysis: pH		Day 28	Yes
Secondary	Urinalysis: protein		Day 28	Yes
Secondary	Urinalysis: glucose		Day 28	Yes
Secondary	Urinalysis: acetone		Day 28	Yes
Secondary	Urinalysis: blood		Day 28	Yes
Secondary	Urinalysis: urobilinogen		Day 28	Yes