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

NCT ID: NCT02540759

Last Updated: 2016-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-03-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

High oleic sunflower oil (HOSO)

10 ml HOSO/day in a single dose, 28 days

Group Type: PLACEBO_COMPARATOR

High Oleic Sunflower Oil

Intervention Type: DIETARY_SUPPLEMENT

High dose Buglossoides oil

10 ml Buglossoides oil/day in a single dose, 28 days

Group Type: EXPERIMENTAL

Buglossoides oil

Intervention Type: DIETARY_SUPPLEMENT

Medium dose Buglossoides oil

6 ml Buglossoides oil + 4 ml HOSO/day in a single dose, 28 days

Group Type: EXPERIMENTAL

Buglossoides oil

Intervention Type: DIETARY_SUPPLEMENT

High Oleic Sunflower Oil

Intervention Type: DIETARY_SUPPLEMENT

Low dose Buglossoides oil

3 ml Buglossoides oil + 7 ml HOSO/day in a single dose, 28 days

Group Type: EXPERIMENTAL

Buglossoides oil

Intervention Type: DIETARY_SUPPLEMENT

High Oleic Sunflower Oil

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Buglossoides oil

Intervention Type: DIETARY_SUPPLEMENT

High Oleic Sunflower Oil

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Ahiflower; HOSO

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).

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Réseau de Santé Vitalité Health Network

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Surette, PhD

Role: PRINCIPAL_INVESTIGATOR

Université de Moncton, Moncton, NB, Canada

Locations

Université de Moncton

Moncton, New Brunswick, Canada

Countries

Canada

Other Identifiers

HC-NNHPD-213421

Identifier Type: -

Identifier Source: org_study_id