Accumulation of n-3 Long-chain (LC)-PUFA by Supplementation of SDA-rich Echium Oil in Humans Depending on Age, Gender and Physiological Stage
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- eicosapentaenic acid
研究概览
简要总结
The objective of this study is to investigate the conversion of the precursors ALA and SDA into n-3 LC-PUFA (EPA, DPA and DHA) in humans by oral supplementation of Echium oil in comparison with SDA soybean oil (positive control). In addition, the accumulation of n-3 LC-PUFA is compared between subpopulations of different age, gender and physiological conditions (overweight, increased serum total cholesterol).
详细描述
N-3 PUFA are important for human health and nutrition. Due to the increasing world population, overfishing of the seas and generally low amounts of n-3 PUFA in major oil crops, there is a demand for new sources of n-3 PUFA.
One approach involves searching for potential vegetable sources of n-3 PUFA; especially those rich in ALA and SDA. The conversion of ALA to SDA in humans depends on the rate-limiting ∆6-desaturation. Plant-derived SDA is therefore a promising precursor regarding endogenous synthesis of n-3 LC-PUFA in humans. The enrichment of n-3 LC-PUFA in human lipids during the supplementation of ALA- and SDA-rich Echium oil will be compared with SDA-rich soybean oil.
Eighty volunteers will be recruited and allocated into four study groups depending on age and BMI. Three groups (each n=20) will receive daily ca. 20 g Echium oil ( group 1 and 2: mean BMI < 25, with mean age: 25 or 55 years; group 3: mean age 55 and BMI > 25). One group (n=20) will receive SDA soybean oil ( dose with comparable amount of SDA; BMI < 25; mean age 25 and 55). The double-blind, randomized, parallel-designed study will start with a two-weeks run-in period, followed by an eight-weeks supplementation period. After the run-in period, one week and eight weeks of oil supplementation blood will be drawn and 24-h urine will be sampled.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy subjects
排除标准
- •cholesterol lowering drugs
- •chronic diseases
- •pregnancy, lactation
- •intake of nutritional supplements
研究组 & 干预措施
Echium oil young
BMI<25,
age 20-30
干预措施: Echium oil (Dietary Supplement)
Echium oil older
age 40-70 BMI <25
干预措施: Echium oil (Dietary Supplement)
Echium oil older, overweight
age 40-70 BMI >25
干预措施: Echium oil (Dietary Supplement)
结局指标
主要结局
eicosapentaenic acid
时间窗: after 0,7, 56 days
eicosapentaenic acid in lipids of plasma, erythrocytes and peripheral mononuclear cells (% of total identified fatty acid methyl esters)
次要结局
- Lipid mediators derived from AA, EPA and DGLA such as HETE species (5-HETE; 8-HETE, etc.)(0 and 56 days)
研究者
Gerhard Jahreis
Prof. Dr. habil.
University of Jena
