NCT02226354

Study of the Safety and Efficacy of Dietary Buglossoides Oil

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Réseau de Santé Vitalité Health Network · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ahiflower oil	9.73 ml per day for 28 days
DIETARY_SUPPLEMENT	Flaxseed oil	9.73ml per day for 28 days

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2014-08-27
• Last updated: 2015-09-02

Locations

1 site across 1 country: Canada