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临床试验/NCT02226354
NCT02226354已完成1 期

Study of the Safety and Efficacy of Dietary Buglossoides Oil

Réseau de Santé Vitalité Health Network2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年5月1日最近更新:
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适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Plasma eicosapentaenoic acid (EPA) concentration
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years（Adult, Older Adult）
性别
All
接受健康志愿者
是

入选标准

  • •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.
  • •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.

排除标准

  • •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.
  • •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
  • •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.

结局指标

主要结局

Plasma eicosapentaenoic acid (EPA) concentration

时间窗: Day 0, Day 14, Day 28

Expressed as μmol/L plasma

次要结局

  • Fasting serum chemistry: blood urea nitrogen(Day 0, Day 14, Day 28)
  • Plasma eicosatetraenoic acid (ETA) concentration(Day 0, Day 14, Day 28)
  • Omega-3 index (defined as the sum of red blood cell EPA and DHA concentrations)(Day 0, Day 14, Day 28)
  • Fasting serum chemistry: glucose(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)
  • Neutrophil 20:4n-3, EPA and DPA individually as % of total fatty acids(Day 0, Day 14, Day 28)
  • Fasting serum chemistry: potassium(Day 0, Day 14, Day 28)
  • Fasting serum chemistry: calcium(Day 0, Day 14, Day 28)
  • Fasting serum chemistry: sodium(Day 0, Day 14, Day 28)
  • Fasting serum chemistry: creatinine(Day 0, Day 14, Day 28)
  • Fasting serum chemistry: alkaline phosphatase(Day 0, Day 14, Day 28)
  • Fasting serum chemistry: aspartate aminotransferase(Day 0, Day 14, Day 28)
  • Fasting serum chemistry: amylase(Day 0, Day 14, Day 28)
  • Fasting serum chemistry: uric acid(Day 0, Day 14, Day 28)
  • Fasting serum chemistry: albumin(Day 0, Day 14, Day 28)
  • Fasting hematology profile: white blood cell count(Day 0, Day 14, Day 28)
  • Fasting hematology profile: hemoglobin(Day 0, Day 14, Day 28)
  • Fasting serum chemistry: gamma-glutamyl transferase(Day 0, Day 14, Day 28)
  • Fasting serum chemistry: total bilirubin(Day 0, Day 14, Day 28)
  • Fasting hematology profile: red blood cell count(Day 0, Day 14, Day 28)
  • Fasting hematology profile: neutrophil count(Day 0, Day 14, Day 28)
  • Fasting hematology profile: platelet count(Day 0, Day 14, Day 28)
  • Fasting hematology profile: hematocrit(Day 0, Day 14, Day 28)
  • Fasting blood lipid profile: triglycerides(Day 0, Day 14, Day 28)
  • Fasting blood lipid profile: LDL-C(Day 0, Day 14, Day 28)
  • Fasting blood lipid profile: HDL-C(Day 0, Day 14, Day 28)
  • Fasting blood lipid profile: total cholesterol(Day 0, Day 14, Day 28)
  • Fasting blood lipid profile: non HDL-C(Day 0, Day 14, Day 28)
  • Fasting serum chemistry: chlorides(Day 0, Day 14, Day 28)
  • Estimated glomerular filtration rate(Day 0, Day 14, Day 28)
  • Fasting serum chemistry: direct bilirubin(Day 0, Day 14, Day 28)
  • Fasting hematology profile: mean corpuscular volume(Day 0, Day 14, Day 28)
  • Fasting hematology profile: mean corpuscular hemoglobin(Day 0, Day 14, Day 28)
  • Fasting hematology profile: mean corpuscular hemoglobin concentration(Day 0, Day 14, Day 28)
  • Fasting hematology profile: red cell distribution width(Day 0, Day 14, Day 28)
  • Fasting hematology profile: immature granulocytes count(Day 0, Day 14, Day 28)
  • Fasting hematology profile: immature granulocytes (% of WBC)(Day 0, Day 14, Day 28)
  • Fasting hematology profile: mean platelet volume(Day 0, Day 14, Day 28)
  • Fasting hematology profile: lymphocyte concentration(Day 0, Day 14, Day 28)
  • Fasting hematology profile: basophil count(Day 0, Day 14, Day 28)
  • Fasting hematology profile: monocyte count(Day 0, Day 14, Day 28)
  • Fasting hematology profile: eosinophil count(Day 0, Day 14, Day 28)
  • Fasting hematology profile: neutrophil (% of WBC)(Day 0, Day 14, Day 28)
  • Fasting hematology profile: lymphocyte (% of WBC)(Day 0, Day 14, Day 28)
  • Fasting hematology profile: monocyte (% of WBC)(Day 0, Day 14, Day 28)
  • Fasting hematology profile: eosinophil (% of WBC)(Day 0, Day 14, Day 28)
  • Fasting hematology profile: basophil (% of WBC)(Day 0, Day 14, Day 28)

研究者

发起方
Réseau de Santé Vitalité Health Network
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marc Surette

Professor

Réseau de Santé Vitalité Health Network

研究点 (2)

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