Study of the Safety and Efficacy of Dietary Buglossoides Oil

Healthy Clinical Trial

Official title:

Study of the Safety and Efficacy of Dietary Buglossoides Oil

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02226354
• Other study ID #: HC-NHPD-196699
• Status: Completed
• Phase: Phase 1
• First received: August 6, 2014
• Last updated: September 1, 2015
• Start date: May 2014
• Est. completion date: September 2014

Study information

• Verified date: September 2015
• Source: Réseau de Santé Vitalité Health Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Seeds from the Buglossoides arvensis plant (trademarked as Ahiflower™) produce oil that is a rich natural source (20%) of stearidonic acid (SDA), a metabolic intermediate between omega-3 fatty acids found in other plants (such as flax) and those found in fish oils.

The objectives of this study to collect safety data and to investigate the accumulation of long chain n-3 polyunsaturated fatty acids in human lipids following oral supplementation with Ahiflower oil in healthy adults.

Description:

This is a single-center, randomized, comparator-controlled, double-blind study in healthy subjects. Forty subjects will be randomly assigned to 2 supplementation groups (n=20 per group). One group will consume 10 ml of Buglossoides oil daily and one group will consume 10 ml of flax seed oil daily for a 4 week period. Baseline data will be obtained at week 0. Subjects will return to the clinic after 2 weeks and again after 4 weeks for measurement of safety and efficacy endpoints.

The efficacy parameters are statistically significant changes from baseline and between groups in plasma, red blood cell and leukocyte omega-3 fatty acid content.

The primary efficacy endpoint will be:

Plasma EPA concentration expressed as μmol/L plasma.

The secondary efficacy endpoints will be:

1. Plasma 20:4n-3 and DPA individually as μmol/L;

2. Plasma 20:4n-3, EPA and DPA individually as % of total fatty acids;

3. Erythrocyte 20:4n-3, EPA and DPA individually as % of total fatty acids;

4. Mononuclear cell 20:4n-3, EPA and DPA individually as % of total fatty acids;

5. Neutrophil 20:4n-3, EPA and DPA individually as % of total fatty acids;

6. The omega-3 index (defined as the sum of red blood cell EPA and DHA concentrations), expressed as % total fatty acids.

Safety endpoints will be:

1. fasting serum chemistry

2. fasting hematology profile

3. fasting blood lipid profile

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

• 18 to 65 years of age, inclusive.

• Body mass index (BMI) 18 - 35 kg/m2

• Subject is willing to avoid alcohol consumption for 24h prior to every clinic visit.

• The subject will not modify smoking habits during supplementation period.

• No significant medical conditions that in the opinion of the qualified physician, would preclude the subject's participation in the study.

• Signed informed consent.

• 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.

• Willing to not consume fish, crustaceans and shellfish for the duration of the study.

Exclusion Criteria:

• 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.

• 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.

• 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.

• History or presence of significant, renal, hepatic, gastrointestinal, pulmonary, biliary, neurological or endocrine disorders.

• 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).

• 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, alkaline phosphatase or aspartate aminotransferase = 1.5 times the upper limit of normal.

• Currently being treated for angina, arrhythmia and/or congestive heart failure. History of myocardial infarction or stroke.

• Presence of coronary heart disease or presence of multiple risk factors that result in a greater than 20% chance for developing coronary artery disease within 10 years using the Framingham risk index.

• Uncontrolled hypertension (resting systolic blood pressure = 160 mmHg or diastolic blood pressure = 100 mmHg).

• Type 1 or 2 diabetes. Fasting glucose = 100 mg/dL. HbA1c = 6.0.

• If a smoker, subject smokes no more than 1 pack (20 cigarettes) daily.

• 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).

• Use of any lipid-altering medications (statins, bile acid sequestrants, cholesterol absorption inhibitors, fibrates, prescription formulations of niacin).

• Unstable use of thyroid medication. Stable, treated hypothyroidism is not an exclusion criteria.

• 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.

• Currently taking fish oil or any other omega-3 or omega-6 polyunsaturated fatty acid supplement/drug within three months of Visit 1 and throughout the study. Consumption of fatty fish (salmon, herring, mackerel, albacore tuna, and sardines) more than twice a month within three months of visit 1 and throughout the study period. Consumption (more than twice a month) of any EPA/DHA enriched foods (e.g. DHA-enriched eggs) within three months of Visit 1. Unwillingness to avoid all fish including shellfish and crustaceans throughout the study period.

• Use of alpha-linolenic acid-containing seeds and oils such as flax seed, perilla seed, hemp, spirulina, walnut, mustard seed or black currant seeds/oil within three months of Visit 1 and throughout the study.

• Use of an investigational product within the previous 30 days.

• Has donated blood up to 8 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: Prevention

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Ahiflower oil
9.73 ml per day for 28 days
• Flaxseed oil
9.73ml per day for 28 days

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
Primary	Plasma eicosapentaenoic acid (EPA) concentration	Expressed as µmol/L plasma	Day 0, Day 14, Day 28	No
Secondary	Plasma eicosatetraenoic acid (ETA) concentration	Expressed as µmol/L	Day 0, Day 14, Day 28	No
Secondary	Plasma docosapentaenoic acid (DPA) concentration	Expressed as µmol/L	Day 0, Day 14, Day 28	No
Secondary	Plasma 20:4n-3, EPA and DPA individually as % of total fatty acids		Day 0, Day 14, Day 28	No
Secondary	Erythrocyte 20:4n-3, EPA and DPA individually as % of total fatty acids		Day 0, Day 14, Day 28	No
Secondary	Mononuclear cell 20:4n-3, EPA and DPA individually as % of total fatty acids		Day 0, Day 14, Day 28	No
Secondary	Neutrophil 20:4n-3, EPA and DPA individually as % of total fatty acids		Day 0, Day 14, Day 28	No
Secondary	Omega-3 index (defined as the sum of red blood cell EPA and DHA concentrations)	Expressed as % total fatty acids	Day 0, Day 14, Day 28	No
Secondary	Fasting serum chemistry: glucose		Day 0, Day 14, Day 28	Yes
Secondary	Fasting serum chemistry: calcium		Day 0, Day 14, Day 28	Yes
Secondary	Fasting serum chemistry: sodium		Day 0, Day 14, Day 28	Yes
Secondary	Fasting serum chemistry: potassium		Day 0, Day 14, Day 28	Yes
Secondary	Fasting serum chemistry: blood urea nitrogen		Day 0, Day 14, Day 28	Yes
Secondary	Fasting serum chemistry: creatinine		Day 0, Day 14, Day 28	Yes
Secondary	Fasting serum chemistry: alkaline phosphatase		Day 0, Day 14, Day 28	Yes
Secondary	Fasting serum chemistry: aspartate aminotransferase		Day 0, Day 14, Day 28	Yes
Secondary	Fasting serum chemistry: gamma-glutamyl transferase		Day 0, Day 14, Day 28	Yes
Secondary	Fasting serum chemistry: total bilirubin		Day 0, Day 14, Day 28	Yes
Secondary	Fasting serum chemistry: amylase		Day 0, Day 14, Day 28	Yes
Secondary	Fasting serum chemistry: uric acid		Day 0, Day 14, Day 28	Yes
Secondary	Fasting serum chemistry: albumin		Day 0, Day 14, Day 28	Yes
Secondary	Fasting hematology profile: white blood cell count		Day 0, Day 14, Day 28	Yes
Secondary	Fasting hematology profile: neutrophil count		Day 0, Day 14, Day 28	Yes
Secondary	Fasting hematology profile: red blood cell count		Day 0, Day 14, Day 28	Yes
Secondary	Fasting hematology profile: hemoglobin		Day 0, Day 14, Day 28	Yes
Secondary	Fasting hematology profile: hematocrit		Day 0, Day 14, Day 28	Yes
Secondary	Fasting hematology profile: platelet count		Day 0, Day 14, Day 28	Yes
Secondary	Fasting blood lipid profile: triglycerides		Day 0, Day 14, Day 28	Yes
Secondary	Fasting blood lipid profile: total cholesterol		Day 0, Day 14, Day 28	Yes
Secondary	Fasting blood lipid profile: LDL-C		Day 0, Day 14, Day 28	Yes
Secondary	Fasting blood lipid profile: non HDL-C		Day 0, Day 14, Day 28	Yes
Secondary	Fasting blood lipid profile: HDL-C		Day 0, Day 14, Day 28	Yes
Secondary	Fasting serum chemistry: chlorides		Day 0, Day 14, Day 28	Yes
Secondary	Estimated glomerular filtration rate		Day 0, Day 14, Day 28	Yes
Secondary	Fasting serum chemistry: direct bilirubin		Day 0, Day 14, Day 28	Yes
Secondary	Fasting hematology profile: mean corpuscular volume		Day 0, Day 14, Day 28	Yes
Secondary	Fasting hematology profile: mean corpuscular hemoglobin		Day 0, Day 14, Day 28	Yes
Secondary	Fasting hematology profile: mean corpuscular hemoglobin concentration		Day 0, Day 14, Day 28	Yes
Secondary	Fasting hematology profile: red cell distribution width		Day 0, Day 14, Day 28	Yes
Secondary	Fasting hematology profile: mean platelet volume		Day 0, Day 14, Day 28	Yes
Secondary	Fasting hematology profile: lymphocyte concentration		Day 0, Day 14, Day 28	Yes
Secondary	Fasting hematology profile: monocyte count		Day 0, Day 14, Day 28	Yes
Secondary	Fasting hematology profile: eosinophil count		Day 0, Day 14, Day 28	Yes
Secondary	Fasting hematology profile: basophil count		Day 0, Day 14, Day 28	Yes
Secondary	Fasting hematology profile: immature granulocytes count		Day 0, Day 14, Day 28	Yes
Secondary	Fasting hematology profile: immature granulocytes (% of WBC)		Day 0, Day 14, Day 28	Yes
Secondary	Fasting hematology profile: neutrophil (% of WBC)		Day 0, Day 14, Day 28	Yes
Secondary	Fasting hematology profile: lymphocyte (% of WBC)		Day 0, Day 14, Day 28	Yes
Secondary	Fasting hematology profile: monocyte (% of WBC)		Day 0, Day 14, Day 28	Yes
Secondary	Fasting hematology profile: eosinophil (% of WBC)		Day 0, Day 14, Day 28	Yes
Secondary	Fasting hematology profile: basophil (% of WBC)		Day 0, Day 14, Day 28	Yes