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Effect of Dose of Buglossoides Oil on EPA Accrual and on the Inflammatory Response

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ClinicalTrials.gov Identifier: NCT02540759
Recruitment Status : Completed
First Posted : September 4, 2015
Last Update Posted : March 11, 2016
Sponsor:
Information provided by (Responsible Party):
Réseau de Santé Vitalité Health Network

Brief Summary:
The effect of various doses of Buglossoides oil on the accrual of eicosapentaenoic acid (EPA) in blood and circulating cells will be investigated.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Buglossoides oil Dietary Supplement: High Oleic Sunflower Oil Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Study of the Effect of Dose of Buglossoides Arvensis Oil on Eicosapentaenoic Acid Accrual and on the Inflammatory Response
Study Start Date : September 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Arm Intervention/treatment
Placebo Comparator: High oleic sunflower oil (HOSO)
10 ml HOSO/day in a single dose, 28 days
Dietary Supplement: High Oleic Sunflower Oil
Other Name: HOSO

Experimental: High dose Buglossoides oil
10 ml Buglossoides oil/day in a single dose, 28 days
Dietary Supplement: Buglossoides oil
Other Name: Ahiflower

Experimental: Medium dose Buglossoides oil
6 ml Buglossoides oil + 4 ml HOSO/day in a single dose, 28 days
Dietary Supplement: Buglossoides oil
Other Name: Ahiflower

Dietary Supplement: High Oleic Sunflower Oil
Other Name: HOSO

Experimental: Low dose Buglossoides oil
3 ml Buglossoides oil + 7 ml HOSO/day in a single dose, 28 days
Dietary Supplement: Buglossoides oil
Other Name: Ahiflower

Dietary Supplement: High Oleic Sunflower Oil
Other Name: HOSO




Primary Outcome Measures :
  1. Plasma eicosapentaenoic concentration (EPA) [ Time Frame: Day 28 ]
    Expressed as μmol/L plasma


Secondary Outcome Measures :
  1. Plasma 20:4n-3 [ Time Frame: Day 28 ]
    Expressed as μmol/L plasma

  2. Plasma docosapentaenoic acid (DPA) [ Time Frame: Day 28 ]
    Expressed as μmol/L plasma

  3. Plasma 20:4n-3, EPA and DPA individually as % of total fatty acids [ Time Frame: Day 28 ]
  4. Mononuclear cell 20:4n-3, EPA and DPA individually as % of total fatty acids [ Time Frame: Day 28 ]
  5. Fasting serum chemistry: glucose [ Time Frame: Day 28 ]
  6. Fasting serum chemistry: calcium [ Time Frame: Day 28 ]
  7. Fasting serum chemistry: sodium [ Time Frame: Day 28 ]
  8. Fasting serum chemistry: potassium [ Time Frame: Day 28 ]
  9. Fasting serum chemistry: blood urea nitrogen [ Time Frame: Day 28 ]
  10. Fasting serum chemistry: creatinine [ Time Frame: Day 28 ]
  11. Fasting serum chemistry: alkaline phosphatase [ Time Frame: Day 28 ]
  12. Fasting serum chemistry: aspartate aminotransferase [ Time Frame: Day 28 ]
  13. Fasting serum chemistry: gamma-glutamyltransferase [ Time Frame: Day 28 ]
  14. Fasting serum chemistry: total bilirubin [ Time Frame: Day 28 ]
  15. Fasting serum chemistry: amylase [ Time Frame: Day 28 ]
  16. Fasting serum chemistry: uric acid [ Time Frame: Day 28 ]
  17. Fasting serum chemistry: albumin [ Time Frame: Day 28 ]
  18. Fasting hematology: white blood cell count [ Time Frame: Day 28 ]
  19. Fasting hematology: neutrophil count [ Time Frame: Day 28 ]
  20. Fasting hematology: red blood cell count [ Time Frame: Day 28 ]
  21. Fasting hematology:hemoglobin [ Time Frame: Day 28 ]
  22. Fasting hematology: hematocrit [ Time Frame: Day 28 ]
  23. Fasting hematology: platelet count [ Time Frame: Day 28 ]
  24. Fasting blood lipid profile: triglycerides [ Time Frame: Day 28 ]
  25. Fasting blood lipid profile: total cholesterol [ Time Frame: Day 28 ]
  26. Fasting blood lipid profile: low density lipoprotein cholesterol (LDL-c) [ Time Frame: Day 28 ]
  27. Fasting blood lipid profile: non-high density lipoprotein-cholesterol (non-HDL-c) [ Time Frame: Day 28 ]
  28. Fasting blood lipid profile: HDL-c [ Time Frame: Day 28 ]
  29. Fasting serum chemistry: chloride [ Time Frame: Day 28 ]
  30. Estimated glomerular filtration rate [ Time Frame: Day 28 ]
  31. Fasting hematology profile: mean corpuscular volume [ Time Frame: Day 28 ]
  32. Fasting hematology profile: mean corpuscular hemoglobin [ Time Frame: Day 28 ]
  33. Fasting hematology profile: mean corpuscular hemoglobin concentration [ Time Frame: Day 28 ]
  34. Fasting hematology profile: red cell distribution width [ Time Frame: Day 28 ]
  35. Fasting hematology profile: mean platelet volume [ Time Frame: Day 28 ]
  36. Fasting hematology profile: lymphocyte concentration [ Time Frame: Day 28 ]
  37. Fasting hematology profile: monocyte count [ Time Frame: Day 28 ]
  38. Fasting hematology profile: eosinophil count [ Time Frame: Day 28 ]
  39. Fasting hematology profile: basophil count [ Time Frame: Day 28 ]
  40. Fasting hematology profile: Immature granulocytes count [ Time Frame: Day 28 ]
  41. Fasting hematology profile: immature granulocytes (% white blood cell (WBC)) [ Time Frame: Day 28 ]
  42. Fasting hematology profile: neutrophil (% WBC) [ Time Frame: Day 28 ]
  43. Fasting hematology profile: lymphocyte (% WBC) [ Time Frame: Day 28 ]
  44. Fasting hematology profile: monocytes (% WBC) [ Time Frame: Day 28 ]
  45. Fasting hematology profile: eosinophil (% WBC) [ Time Frame: Day 28 ]
  46. Fasting hematology profile: basophil (% WBC) [ Time Frame: Day 28 ]
  47. Urinalysis: appearance [ Time Frame: Day 28 ]
  48. Urinalysis: density [ Time Frame: Day 28 ]
  49. Urinalysis: leukocyte esterase [ Time Frame: Day 28 ]
  50. Urinalysis: nitrites [ Time Frame: Day 28 ]
  51. Urinalysis: pH [ Time Frame: Day 28 ]
  52. Urinalysis: protein [ Time Frame: Day 28 ]
  53. Urinalysis: glucose [ Time Frame: Day 28 ]
  54. Urinalysis: acetone [ Time Frame: Day 28 ]
  55. Urinalysis: blood [ Time Frame: Day 28 ]
  56. Urinalysis: urobilinogen [ Time Frame: Day 28 ]

Other Outcome Measures:
  1. Cytokine production following ex vivo stimulation: interferon-gamma [ Time Frame: Day 28 ]
  2. Cytokine production following ex vivo stimulation: interleukin-1beta [ Time Frame: Day 28 ]
  3. Cytokine production following ex vivo stimulation: interleukin-6 [ Time Frame: Day 28 ]
  4. Cytokine production following ex vivo stimulation: interleukin-8 [ Time Frame: Day 28 ]
  5. Cytokine production following ex vivo stimulation: interleukin-10 [ Time Frame: Day 28 ]
  6. Cytokine production following ex vivo stimulation: interleukin-17A [ Time Frame: Day 28 ]
  7. Cytokine production following ex vivo stimulation: interleukin-23 [ Time Frame: Day 28 ]
  8. Cytokine production following ex vivo stimulation: monocyte chemoattractant protein-1 [ Time Frame: Day 28 ]
  9. Cytokine production following ex vivo stimulation: tumor necrosis factor-alpha [ Time Frame: Day 28 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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.
  2. 18 to 65 years of age, inclusive.
  3. Body mass index (BMI) 18 - 39.9 kg/m2
  4. Subject is willing to avoid alcohol consumption for 24h prior to every clinic visit.
  5. The subject will not modify smoking habits during supplementation period.
  6. No significant medical conditions that in the opinion of the qualified physician, would preclude the subject's participation in the study.
  7. Signed informed consent.
  8. 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.
  9. Willing to not consume fish, crustaceans and shellfish for the duration of the study.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. History or presence of significant, renal, hepatic, gastrointestinal, pulmonary, biliary, neurological or endocrine disorders.
  5. 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).
  6. 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, alanine transaminase or aspartate aminotransferase ≥ 1.5X the upper limit of normal.
  7. Currently being treated for angina, arrhythmia and/or congestive heart failure. History of myocardial infarction or stroke.
  8. Uncontrolled hypertension (resting systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg).
  9. Type 1 or 2 diabetes. Fasting glucose ≥ 100 mg/dL. HbA1c ≥ 6.0.
  10. If a smoker, subject smokes no more than 1 pack (20 cigarettes) daily.
  11. 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).
  12. Use of any lipid-altering medications (statins, bile acid sequestrants, cholesterol absorption inhibitors, fibrates, over the counter and prescription formulations of niacin).
  13. Unstable use of thyroid medication. Stable, treated hypothyroidism is not an exclusion criteria.
  14. 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.
  15. Currently taking fish oil or any other omega-3 or omega-6 polyunsaturated fatty acids (PUFA) supplement/drug within one month of Visit 1 and throughout the study. Consumption of fatty fish (salmon, herring, mackerel, albacore tuna, and sardines) more than 2X a month within one month of visit 1 and throughout the study period. Consumption (more than twice a month) of any EPA/DHA enriched foods (e.g. docosahexaenoic acid (DHA)-enriched eggs) within one month of Visit 1. Unwillingness to avoid all fish including shellfish and crustaceans throughout the study period.
  16. Use of alpha-linolenic acid-containing seeds and oils such as flax seed, chia seed, perilla seed, hemp, spirulina, walnut, mustard seed or black currant seeds/oil within one month of Visit 1 and throughout the study.
  17. Use of an investigational product within the previous 30 days.
  18. Has donated blood up to 4 weeks before the start of the study. Not willing to cease being a blood donor during the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02540759


Locations
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Canada, New Brunswick
Université de Moncton
Moncton, New Brunswick, Canada, E1A 3E9
Sponsors and Collaborators
Réseau de Santé Vitalité Health Network
Investigators
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Principal Investigator: Marc Surette, PhD Université de Moncton, Moncton, NB, Canada

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Responsible Party: Réseau de Santé Vitalité Health Network
ClinicalTrials.gov Identifier: NCT02540759     History of Changes
Other Study ID Numbers: HC-NNHPD-213421
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: March 11, 2016
Last Verified: March 2016
Keywords provided by Réseau de Santé Vitalité Health Network:
Buglossoides arvensis
vegetable oil
omega-3 fatty acids
participants