Bioavailability of EPA + DHA Enriched Canned Tuna and Its Acute Effects on Cardiovascular Risk Markers, in Healthy Human Volunteers
试验速览
- 阶段
- 2 期
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Change in postprandial plasma total cholesterol concentrations
研究概览
简要总结
Evidence has suggested that omega-3 fatty acids, namely eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), have an important role in promoting cardiovascular health. However, the currently available scientific literature describing the postprandial effects and bioavailability of these fatty acids, particularly when they are incorporated into high protein food item, like canned tuna, is far from conclusive.
The aim of this study is to evaluate the acute bioavailability of EPA + DHA enriched canned tuna and its acute effects on cardiovascular risk markers, in healthy human volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult men or women
- •Age 18 - 59 years
- •Willing to maintain usual diet and physical activity patterns
- •Willing to comply with study protocol and procedures
- •Willing to provide written informed consent
排除标准
- •Pregnant, breastfeeding or planning to become pregnant within the study period
- •Subjects with current or previous cardiovascular disease (ischemic cardiovascular disease, angina stable or unstable; myocardial infarction, stroke or symptomatic peripheral arteriosclerosis)
- •Subjects with liver or kidney diseases or cancer
- •Diabetes mellitus (fasting glycemia> 126 mg / dL)
- •Uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg)
- •Subjects with history of drug, alcohol or other substances abuse, or other factors limiting their ability to cooperate during the study
- •Subjetcs with gastrointestinal disorder or under prescription for medication affecting gastrointestinal function or absorption of nutrients
- •Known allergy (or sensitivity) to omega-3 fatty acids, fish (tuna), crustaceans, lactose or any meal ingredient
- •With antihypertensive therapy
- •Health condition that prevents compliance with study requirements
- •Subjects under prescription for medication for digestive symptoms such as anti-spasmodic, laxatives and anti-diarrheic drugs or other digestive auxiliaries
- •Subjects under prescription of anticoagulant drugs
- •Dietary patterns or supplement use that could interfere with study evaluations
- •Subjects not willing to avoid the consumption of fish oil or food supplements, including fatty acids, during the study (except as indicated in the study protocol)
- •Use of antibiotics in the last 4 weeks and laxatives in the last 2 weeks
研究组 & 干预措施
Canned tuna + fish oil (5 g EPA + DHA)
Meal containing canned tuna + fish oil (5 g EPA + DHA)
干预措施: Meal containing canned tuna + fish oil (5 g EPA + DHA) (Dietary Supplement)
Canned tuna + soybean oil
Meal containing canned tuna + soybean oil
干预措施: Meal containing canned tuna + soybean oil (Dietary Supplement)
结局指标
主要结局
Change in postprandial plasma total cholesterol concentrations
时间窗: Up to 5 hours post-meal.
Impact on the postprandial levels of total cholesterol (0, 1, 2, 3, 4, and 5 hours post-meal).
Change in postprandial plasma triglycerides concentrations
时间窗: Up to 5 hours post-meal.
Impact on the postprandial levels of triglycerides (0, 1, 2, 3, 4, and 5 hours post-meal).
Change in postprandial plasma low-density lipoprotein (LDL) cholesterol concentrations
时间窗: Up to 5 hours post-meal.
Impact on the postprandial levels of LDL cholesterol (0, 1, 2, 3, 4, and 5 hours post-meal).
次要结局
- Change in postprandial plasma high-density lipoprotein (HDL) cholesterol concentrations(Up to 5 hours post-meal.)
- Change in postprandial plasma eicosapentaenoic acid (EPA) concentrations(Up to 5 hours post-meal.)
- Change in postprandial plasma docosahexaenoic acid (DHA) concentrations(Up to 5 hours post-meal.)
- Change in postprandial plasma blood glucose concentrations(Up to 5 hours post-meal.)
- Change in postprandial plasma Apolipoprotein B-48 (apoB-48) concentrations(Up to 5 hours post-meal.)
- Change in postprandial blood pressure(Up to 5 hours post-meal.)
- Change in postprandial plasma insulin concentrations(Up to 5 hour post-meal.)