跳至主要内容
临床试验/NCT04288544
NCT04288544已完成不适用

Pilot Study "Health Promoting Effects of the Microalgae Phaeodactylum Tricornutum"

University of Hohenheim2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年2月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
change of concentration of omega-3 fatty acids in blood plasma

研究概览

简要总结

The aim of the research project is to investigate the uptake of omega-3 fatty acids into the blood plasma through the consumption of the microalgae Phaeodactylum tricornutum (PT) in a human study. In an open, crossover study, the volunteers will receive a drink enriched with the microalgae P. tricornutum or an omega-3 fatty acid preparation or (optionally) pollock for 14 days each. Since the microalgae P. tricornutum is rich in omega-3 fatty acids, the target parameter chosen is the uptake of omega-3 fatty acids in the blood plasma

详细描述

A large number of diet-related diseases, such as obesity, are characterized by subclinical inflammation of the body. For this reason, anti-inflammatory foods such as omega-3 fatty acids, which are found in fish and nuts, are used. However, the disadvantage of fish as a resource is its limited availability. Therefore, it is of great interest to provide a resource-saving diet that still supplies us with all macro and micro nutrients. For this reason, microalgae have become the focus of science in recent years. Microalgae not only serve as a source of protein, but also contain a large number of nutrients that could have possible physiological and preventive effects in human nutrition. These include substances from the group of carotenoids and the various polyunsaturated FS found in microalgae.

The microalgae PT is rich in omega-3 FS eicosapentaenoic acid (EPA), which is otherwise found mainly in fatty fish, and could therefore be an alternative or vegetarian source of polyunsaturated fatty acids.

Previous work by U. Neumann has shown that the microalgae P. tricornutum could be used for human nutrition. No toxic effects could be observed in vivo and the bioavailability of fatty acids and proteins could also be successfully demonstrated. In vitro experiments also showed a more anti-inflammatory, anti-oxidative and anti-proliferative effect on human blood cells. For this reason, a health-promoting effect is also possible in human nutrition, but this must be proven in human studies.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Signed declaration of consent
  • •Willingness to follow the prescribed diet for the duration of the study
  • •No participation in another clinical trial (current or within the last 30 days)

排除标准

  • •Taking intestinal therapeutics, antibiotics, immunosuppressive drugs or similar (if necessary, individual case decision)
  • •Pregnancy/nursing period
  • •Relevant violations of the food protocol
  • •Occurrence of relevant diseases (if necessary, individual case decision)
  • •Revocation of consent
  • •Accommodation in a clinic or similar institution due to official or court order

研究组 & 干预措施

Experimental: Intervention group

Active Comparator

The patients get 1x 5,3g per day the microalgae Phaeodactylum tricornutumover for two weeks.

干预措施: Omega-3-fatty acid capsule (Dietary Supplement)

Experimental: Intervention group

Active Comparator

The patients get 1x 5,3g per day the microalgae Phaeodactylum tricornutumover for two weeks.

干预措施: sea fish (Dietary Supplement)

Omega-3 capsules

Active Comparator

The patients get one capsule per day of the Omega-3-fatty acid capsules for 2 weeks.

干预措施: Microalgae (Dietary Supplement)

Omega-3 capsules

Active Comparator

The patients get one capsule per day of the Omega-3-fatty acid capsules for 2 weeks.

干预措施: sea fish (Dietary Supplement)

sea fish (facultative)

Experimental

as positive control, one portion of fish is eaten per week for 2 weeks after the Intervention of 8 weeks and 2 wash out (omega 3 must not be eaten).

干预措施: Microalgae (Dietary Supplement)

sea fish (facultative)

Experimental

as positive control, one portion of fish is eaten per week for 2 weeks after the Intervention of 8 weeks and 2 wash out (omega 3 must not be eaten).

干预措施: Omega-3-fatty acid capsule (Dietary Supplement)

结局指标

主要结局

change of concentration of omega-3 fatty acids in blood plasma

时间窗: Study examinations are before intervention, after 2,3,4,6,7,8, 10,11 and 12 weeks.

concentration of fatty acids from plasma by direct transesterification and subsequent measurement on gas chromatography.

次要结局

  • change of concentration of amino acids and carotenoids (fucoxanthin)(Study examinations are before intervention, after 2,3,4,6,7,8, 10,11 and 12 weeks.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephan C. Bischoff, MD, Professor

Professor

University of Hohenheim

研究点 (2)

Loading locations...

相似试验

"Health Promoting Effects of the Microalgae... | 临床试验