Study of the Safety and Efficacy of Dietary Buglossoides Oil

NCT02226354 | Completed Phase 1

• 1 other identifier: HC-NHPD-196699
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Dietary vegetable oil; Stearidonic acid; Tissue; Fatty Acid; composition

Outcome Measures

Primary Outcomes (1)

• Plasma eicosapentaenoic acid (EPA) concentration

  Expressed as μmol/L plasma

  Day 0, Day 14, Day 28

Secondary Outcomes (50)

• Plasma eicosatetraenoic acid (ETA) concentration

  Day 0, Day 14, Day 28

• Plasma docosapentaenoic acid (DPA) concentration

  Day 0, Day 14, Day 28

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

  Day 0, Day 14, Day 28

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

  Day 0, Day 14, Day 28

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

  Day 0, Day 14, Day 28

Study Arms (2)

Flaxseed oil

ACTIVE COMPARATOR

9.73ml Flaxseed oil once daily, for 28 days

Dietary Supplement: Flaxseed oil

Ahiflower oil

EXPERIMENTAL

9.73ml Ahiflower oil once daily, for 28 days

Dietary Supplement: Ahiflower oil

Interventions

Ahiflower oil DIETARY_SUPPLEMENT

9.73 ml per day for 28 days

Also known as: Buglossoides oil, Buglossoides arvensis oil

Ahiflower oil

Flaxseed oil DIETARY_SUPPLEMENT

9.73ml per day for 28 days

Also known as: Linseed oil

Flaxseed oil

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Réseau de Santé Vitalité Health Network: lead

Study Sites (1)

Université de Moncton

Moncton, New Brunswick, E1A 3E9, Canada

Location

MeSH Terms

Interventions

Linseed Oil

Intervention Hierarchy (Ancestors)

Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Marc Surette, PhD

  Université de Moncton

  PRINCIPAL INVESTIGATOR

• Rémi LeBlanc, MD

  Centre Hospitalier Dr Georges-L.-Dumont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 6, 2014
• First Posted: August 27, 2014
• Study Start: May 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 2, 2015

Record last verified: 2015-09

Locations

CA (1)