Healthy Clinical Trial - Study of the Safety & Efficacy of Dietary

Status Completed

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.

Clinical Trial 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 ;

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

Clinical Trial Details

NCT number	NCT02226354
Study type	Interventional
Source	Réseau de Santé Vitalité Health Network
Contact
Status	Completed
Phase	Phase 1
Start date	May 2014
Completion date	September 2014

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Study of the Safety and Efficacy of Dietary Buglossoides Oil

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms