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临床试验/NCT01856179
NCT01856179已完成早期 1 期

Accumulation of n-3 Long-chain (LC)-PUFA by Supplementation of SDA-rich Echium Oil in Humans Depending on Age, Gender and Physiological Stage

University of Jena1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2011年3月1日最近更新:
适应症
干预措施

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

Experimental

BMI<25,

age 20-30

干预措施: Echium oil (Dietary Supplement)

Echium oil older

Experimental

age 40-70 BMI <25

干预措施: Echium oil (Dietary Supplement)

Echium oil older, overweight

Experimental

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

发起方
University of Jena
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gerhard Jahreis

Prof. Dr. habil.

University of Jena

研究点 (1)

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