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临床试验/NCT05120791
NCT05120791Unknown不适用

Health-promoting Effects of the Microalga Phaeodactylum Tricornutum - Bioavailability and Excretion of Nutrients in Relation to Age and Their Effects on Fatty Acid Status and Inflammatory Markers".

University of Hohenheim1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
Change in omega-6/omega-3 ratio (plasma level basis)

研究概览

简要总结

Investigation of the microalgae Phaeodactylum as food with regard to the uptake of omega-3 fatty acids and effects on various blood parameters in relation to age.

Bioavailability and excretion of nutrients and their effects on fatty acid status and inflammatory markers.

详细描述

Due to a multifaceted redesign of all areas of life, older people face many nutritional challenges, such as cognitive change, sarcopenia and micronutrient deficiency. In addition to age-associated diseases, cognitive decline is usually a precursor to neurodegenerative processes, such as Alzheimer's disease. The full molecular mechanisms are still unknown, but classic aging mechanisms, such as oxidative stress and subclinical inflammation, play a role. Due to the changed life situation, there is a reduced need for energy, while the need for nutrients remains, which greatly increases the risk of malnutrition in old age. This results in an increasing prevalence of sarcopenia. The decrease in muscle mass and strength leads to functional limitations in the elderly and also promotes oxidative stress. This increases the need for antioxidant nutrients such as carotenoids and vitamins. Studies show that age-related chronic subclinical inflammation, such as occurs in the context of an omega-6 fatty acid (-FS) emphasized diet, plays a central role in the pathogenesis of age-associated diseases

Due to this, the microalgae PT could be a goud supplier of nutrients like omega-3 FS, especially eicosapentaenoic acid (EPA), which is otherwise found mainly in fatty fish, and Fucoxanthin, an antioxidant. The investigator study the change of omega-3, -6 and -9 FS in blood plasma, in erythrocytes, as well as the change of fucoxanthin and beta-carotene. The investigator measure blood parameters for safety and control the influence on the intestinal barrier.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 90 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥60 ≤90 years, weight ≥50 kg, generally healthy
  • Signed informed consent form
  • Willingness to follow the prescribed diet for the duration of the study
  • No participation in any other clinical trial (current or within the last 30 days)

排除标准

  • Taking intestinal therapeutics, antibiotics, immunosuppressants or similar. (if necessary, decision on a case-by-case basis)
  • Pregnancy/breastfeeding
  • Relevant violations of the dietary protocol
  • Occurrence of relevant diseases (if necessary, individual case decision)
  • Withdrawal of consent
  • Placement in a clinic or similar facility due to official or court order

结局指标

主要结局

Change in omega-6/omega-3 ratio (plasma level basis)

时间窗: 14 days

fatty acid chromatographic measurement

次要结局

  • Inflammation (CRP)(14 days)
  • Omega-3 fatty acid index(14 days)
  • Uptake of fucoxanthin and beta-carotene(14 days)

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 (1)

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