Determining Contribution of Sex and Genetics to DHA Synthesis Rates Over 12 Weeks of EPA Supplementation in Healthy Individuals
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Plasma DHA synthesis/turnover rates
研究概览
简要总结
The goal of this clinical study is to learn how fast EPA is converted to other molecules, including DHA, with consideration of biological sex and genetics in healthy humans.
The main questions it aims to answer are:
- How fast is EPA converted to DHA in blood, and is the conversion rate affected by sex and a specific genotype we previously identified?
- How do sex and the specific genotypes affect blood DHA levels and other products of DHA in response to dietary EPA?
- How fast does dietary EPA replace blood EPA and other omega-3 fatty acids, and is the rate affected by sex and genotype?
Participants will be asked to take EPA supplements for 12 weeks and provide a series of venous blood samples over the study duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 18.5- 30 kg/m2
排除标准
- •High consumption of n-3 PUFA, including ≥ 2 servings of fish/seafood or EPA/DHA-enriched foods per week
- •Consumption of any supplements containing ALA/EPA/DHA currently or within the previous 6 months
- •Allergies to any component of the study supplement (fish, gelatin etc.)
- •BMI <18.5 kg/m² or >30 kg/m²
- •Women who are pregnant, breastfeeding or planning on becoming pregnant
- •Diagnosis with chronic or communicable diseases
- •Prescription of chronic pharmacological medications (except for oral contraceptives)
- •High blood pressure (systolic or diastolic blood pressure above 130 or 80mmHg, respectively)
- •Hypertriglyceridemia (serum > or = 1.69 mmol/l)
- •Hypercholesterolemia (serum LDL-C > or =5 mmol/l)
- •Anticipated changes in lifestyle within the next 4 months
- •Heavy alcohol use (>3 drinks/day)
- •Major surgery in the last six months
研究组 & 干预措施
EPA Supplementation
32 males and 32 females will be enrolled in the EPA supplementation arm, with an equal number of GA+GG and AA genotypes (rs953413 SNP) among males and females.
干预措施: EPA 2.4g/day (Dietary Supplement)
结局指标
主要结局
Plasma DHA synthesis/turnover rates
时间窗: Day 0, 3, 7, 14, 28, 56, 84
Plasma DHA synthesis/turnover rates (nmol/mL/day) by sex and rs953413 ELOVL2 polymorphism will be determined. DHA synthesis/turnover rates will be calculated from frequent sampling of plasma DHA levels and carbon-13 isotope signatures of DHA (δ13C-DHA) over 12 weeks.
次要结局
- Changes in plasma DHA concentrations (nmol/ml)(Baseline and 12 weeks)
- Plasma EPA turnover rates (nmol/ml/day)(Day 0, 3, 7, 14, 28, 56, 84)
- Plasma half-lives of EPA and downstream n-3 PUFAs(Over 12 weeks)
- Plasma DPAn-3 synthesis/turnover rates (nmol/ml/day)(Day 0, 3, 7, 14, 28, 56, 84)
- Changes in PUFA derived eicosanoid/docosanoid levels(Baseline, 4 weeks and 12 weeks)
研究者
Adam Metherel
Assistant Professor
University of Toronto