HealthyPhase 1NCT02226354
Study of the Safety and Efficacy of Dietary Buglossoides Oil
A Phase 1 study testing Ahiflower oil and Flaxseed oil in people with Healthy, run by Réseau de Santé Vitalité Health Network at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ahiflower oil and Flaxseed oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- May 2014to Sep 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- Plasma 20:4n-3 and DPA individually as μmol/L;
- Plasma 20:4n-3, EPA and DPA individually as % of total fatty acids;
- Erythrocyte 20:4n-3, EPA and DPA individually as % of total fatty acids;
- Mononuclear cell 20:4n-3, EPA and DPA individually as % of total fatty acids;
- Neutrophil 20:4n-3, EPA and DPA individually as % of total fatty acids;
- 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:
- fasting serum chemistry
- fasting hematology profile
- fasting blood lipid profile
- Conditions
- Healthy
- Being tested
- Ahiflower oil, Flaxseed oil
- Keywords
- Dietary vegetable oil, Stearidonic acid, Tissue, Fatty Acid, composition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ahiflower oilDietary supplement
Also called Buglossoides oil, Buglossoides arvensis oil
9.73 ml per day for 28 days
Flaxseed oilDietary supplement
Also called Linseed oil
9.73ml per day for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Flaxseed oil | Active comparator | 9.73ml Flaxseed oil once daily, for 28 days Receives: Dietary Supplement: Flaxseed oil |
| Ahiflower oil | Experimental | 9.73ml Ahiflower oil once daily, for 28 days Receives: Dietary Supplement: Ahiflower oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma eicosapentaenoic acid (EPA) concentration
Expressed as μmol/L plasma
Measured: Day 0, Day 14, Day 28
Secondary outcomes (50)
Plasma eicosatetraenoic acid (ETA) concentration
Expressed as μmol/L
Measured: Day 0, Day 14, Day 28
Plasma docosapentaenoic acid (DPA) concentration
Expressed as μmol/L
Measured: Day 0, Day 14, Day 28
Plasma 20:4n-3, EPA and DPA individually as % of total fatty acids
Measured: Day 0, Day 14, Day 28
Erythrocyte 20:4n-3, EPA and DPA individually as % of total fatty acids
Measured: Day 0, Day 14, Day 28
Mononuclear cell 20:4n-3, EPA and DPA individually as % of total fatty acids
Measured: Day 0, Day 14, Day 28
Neutrophil 20:4n-3, EPA and DPA individually as % of total fatty acids
Measured: Day 0, Day 14, Day 28
Omega-3 index (defined as the sum of red blood cell EPA and DHA concentrations)
Expressed as % total fatty acids
Measured: Day 0, Day 14, Day 28
Fasting serum chemistry: glucose
Measured: Day 0, Day 14, Day 28
Fasting serum chemistry: calcium
Measured: Day 0, Day 14, Day 28
Fasting serum chemistry: sodium
Measured: Day 0, Day 14, Day 28
Fasting serum chemistry: potassium
Measured: Day 0, Day 14, Day 28
Fasting serum chemistry: blood urea nitrogen
Measured: Day 0, Day 14, Day 28
Fasting serum chemistry: creatinine
Measured: Day 0, Day 14, Day 28
Fasting serum chemistry: alkaline phosphatase
Measured: Day 0, Day 14, Day 28
Fasting serum chemistry: aspartate aminotransferase
Measured: Day 0, Day 14, Day 28
Fasting serum chemistry: gamma-glutamyl transferase
Measured: Day 0, Day 14, Day 28
Fasting serum chemistry: total bilirubin
Measured: Day 0, Day 14, Day 28
Fasting serum chemistry: amylase
Measured: Day 0, Day 14, Day 28
Fasting serum chemistry: uric acid
Measured: Day 0, Day 14, Day 28
Fasting serum chemistry: albumin
Measured: Day 0, Day 14, Day 28
Fasting hematology profile: white blood cell count
Measured: Day 0, Day 14, Day 28
Fasting hematology profile: neutrophil count
Measured: Day 0, Day 14, Day 28
Fasting hematology profile: red blood cell count
Measured: Day 0, Day 14, Day 28
Fasting hematology profile: hemoglobin
Measured: Day 0, Day 14, Day 28
Fasting hematology profile: hematocrit
Measured: Day 0, Day 14, Day 28
Fasting hematology profile: platelet count
Measured: Day 0, Day 14, Day 28
Fasting blood lipid profile: triglycerides
Measured: Day 0, Day 14, Day 28
Fasting blood lipid profile: total cholesterol
Measured: Day 0, Day 14, Day 28
Fasting blood lipid profile: LDL-C
Measured: Day 0, Day 14, Day 28
Fasting blood lipid profile: non HDL-C
Measured: Day 0, Day 14, Day 28
Fasting blood lipid profile: HDL-C
Measured: Day 0, Day 14, Day 28
Fasting serum chemistry: chlorides
Measured: Day 0, Day 14, Day 28
Estimated glomerular filtration rate
Measured: Day 0, Day 14, Day 28
Fasting serum chemistry: direct bilirubin
Measured: Day 0, Day 14, Day 28
Fasting hematology profile: mean corpuscular volume
Measured: Day 0, Day 14, Day 28
Fasting hematology profile: mean corpuscular hemoglobin
Measured: Day 0, Day 14, Day 28
Fasting hematology profile: mean corpuscular hemoglobin concentration
Measured: Day 0, Day 14, Day 28
Fasting hematology profile: red cell distribution width
Measured: Day 0, Day 14, Day 28
Fasting hematology profile: mean platelet volume
Measured: Day 0, Day 14, Day 28
Fasting hematology profile: lymphocyte concentration
Measured: Day 0, Day 14, Day 28
Fasting hematology profile: monocyte count
Measured: Day 0, Day 14, Day 28
Fasting hematology profile: eosinophil count
Measured: Day 0, Day 14, Day 28
Fasting hematology profile: basophil count
Measured: Day 0, Day 14, Day 28
Fasting hematology profile: immature granulocytes count
Measured: Day 0, Day 14, Day 28
Fasting hematology profile: immature granulocytes (% of WBC)
Measured: Day 0, Day 14, Day 28
Fasting hematology profile: neutrophil (% of WBC)
Measured: Day 0, Day 14, Day 28
Fasting hematology profile: lymphocyte (% of WBC)
Measured: Day 0, Day 14, Day 28
Fasting hematology profile: monocyte (% of WBC)
Measured: Day 0, Day 14, Day 28
Fasting hematology profile: eosinophil (% of WBC)
Measured: Day 0, Day 14, Day 28
Fasting hematology profile: basophil (% of WBC)
Measured: Day 0, Day 14, Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startMay 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Réseau de Santé Vitalité Health Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Surette, Réseau de Santé Vitalité Health Network
- Investigators
- Marc Surette, PhD, Principal investigator, Université de MonctonRémi LeBlanc, MD, Principal investigator, Centre Hospitalier Dr Georges-L.-Dumont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226354
- Sponsor's protocol ID
- HC-NHPD-196699
- Status last verified
- Sep 2015
- First submitted
- 6 Aug 2014
- Last updated
- 2 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Safety and Efficacy of Dietary Buglossoides Oil
- ClinicalTrials.gov ID
- NCT02226354
- Acronym / sponsor ID
- HC-NHPD-196699
- Conditions
- Healthy
- Keywords
- Dietary vegetable oil, Stearidonic acid, Tissue, Fatty Acid, composition
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Réseau de Santé Vitalité Health NetworkUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 27 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Plasma 20:4n-3 and DPA individually as μmol/L;
- Plasma 20:4n-3, EPA and DPA individually as % of total fatty acids;
- Erythrocyte 20:4n-3, EPA and DPA individually as % of total fatty acids;
- Mononuclear cell 20:4n-3, EPA and DPA individually as % of total fatty acids;
- Neutrophil 20:4n-3, EPA and DPA individually as % of total fatty acids;
- 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:
- fasting serum chemistry
- fasting hematology profile
- fasting blood lipid profile
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flaxseed oil | Active comparator | Dietary Supplement: Flaxseed oil9.73ml Flaxseed oil once daily, for 28 days |
| Ahiflower oil | Experimental | Dietary Supplement: Ahiflower oil9.73ml Ahiflower oil once daily, for 28 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (19 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ahiflower oilAlso: Buglossoides oil, Buglossoides arvensis oil9.73 ml per day for 28 days | Dietary supplement | Ahiflower oil |
| Flaxseed oilAlso: Linseed oil9.73ml per day for 28 days | Dietary supplement | Flaxseed oil |
Primary outcome
Plasma eicosapentaenoic acid (EPA) concentration
Time frame: Day 0, Day 14, Day 28
Expressed as μmol/L plasma
50 secondary outcomes
Plasma eicosatetraenoic acid (ETA) concentration
Time frame: Day 0, Day 14, Day 28
Plasma docosapentaenoic acid (DPA) concentration
Time frame: Day 0, Day 14, Day 28
Plasma 20:4n-3, EPA and DPA individually as % of total fatty acids
Time frame: Day 0, Day 14, Day 28
Erythrocyte 20:4n-3, EPA and DPA individually as % of total fatty acids
Time frame: Day 0, Day 14, Day 28
Mononuclear cell 20:4n-3, EPA and DPA individually as % of total fatty acids
Time frame: Day 0, Day 14, Day 28
Neutrophil 20:4n-3, EPA and DPA individually as % of total fatty acids
Time frame: Day 0, Day 14, Day 28
Omega-3 index (defined as the sum of red blood cell EPA and DHA concentrations)
Time frame: Day 0, Day 14, Day 28
Fasting serum chemistry: glucose
Time frame: Day 0, Day 14, Day 28
Fasting serum chemistry: calcium
Time frame: Day 0, Day 14, Day 28
Fasting serum chemistry: sodium
Time frame: Day 0, Day 14, Day 28
Fasting serum chemistry: potassium
Time frame: Day 0, Day 14, Day 28
Fasting serum chemistry: blood urea nitrogen
Time frame: Day 0, Day 14, Day 28
Fasting serum chemistry: creatinine
Time frame: Day 0, Day 14, Day 28
Fasting serum chemistry: alkaline phosphatase
Time frame: Day 0, Day 14, Day 28
Fasting serum chemistry: aspartate aminotransferase
Time frame: Day 0, Day 14, Day 28
Fasting serum chemistry: gamma-glutamyl transferase
Time frame: Day 0, Day 14, Day 28
Fasting serum chemistry: total bilirubin
Time frame: Day 0, Day 14, Day 28
Fasting serum chemistry: amylase
Time frame: Day 0, Day 14, Day 28
Fasting serum chemistry: uric acid
Time frame: Day 0, Day 14, Day 28
Fasting serum chemistry: albumin
Time frame: Day 0, Day 14, Day 28
Fasting hematology profile: white blood cell count
Time frame: Day 0, Day 14, Day 28
Fasting hematology profile: neutrophil count
Time frame: Day 0, Day 14, Day 28
Fasting hematology profile: red blood cell count
Time frame: Day 0, Day 14, Day 28
Fasting hematology profile: hemoglobin
Time frame: Day 0, Day 14, Day 28
Fasting hematology profile: hematocrit
Time frame: Day 0, Day 14, Day 28
Fasting hematology profile: platelet count
Time frame: Day 0, Day 14, Day 28
Fasting blood lipid profile: triglycerides
Time frame: Day 0, Day 14, Day 28
Fasting blood lipid profile: total cholesterol
Time frame: Day 0, Day 14, Day 28
Fasting blood lipid profile: LDL-C
Time frame: Day 0, Day 14, Day 28
Fasting blood lipid profile: non HDL-C
Time frame: Day 0, Day 14, Day 28
Fasting blood lipid profile: HDL-C
Time frame: Day 0, Day 14, Day 28
Fasting serum chemistry: chlorides
Time frame: Day 0, Day 14, Day 28
Estimated glomerular filtration rate
Time frame: Day 0, Day 14, Day 28
Fasting serum chemistry: direct bilirubin
Time frame: Day 0, Day 14, Day 28
Fasting hematology profile: mean corpuscular volume
Time frame: Day 0, Day 14, Day 28
Fasting hematology profile: mean corpuscular hemoglobin
Time frame: Day 0, Day 14, Day 28
Fasting hematology profile: mean corpuscular hemoglobin concentration
Time frame: Day 0, Day 14, Day 28
Fasting hematology profile: red cell distribution width
Time frame: Day 0, Day 14, Day 28
Fasting hematology profile: mean platelet volume
Time frame: Day 0, Day 14, Day 28
Fasting hematology profile: lymphocyte concentration
Time frame: Day 0, Day 14, Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Surette, PhD principal investigator
Université de Moncton
Rémi LeBlanc, MD principal investigator
Centre Hospitalier Dr Georges-L.-Dumont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ahiflower oil and Flaxseed oil in people with Healthy, run by Réseau de Santé Vitalité Health Network at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma eicosapentaenoic acid (EPA) concentration (time frame: Day 0, Day 14, Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2015.