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临床试验/NCT01192269
NCT01192269已完成不适用

Buccal Cheek Cells - a New Non-invasive Fatty Acid Status Marker

Ludwig-Maximilians - University of Munich2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2010年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
2
主要终点
Phospholipids in buccal cheek cells

研究概览

简要总结

Various biological materials have been investigated to determine dietary fatty acid intakes, such as plasma, erythrocytes, and adipose tissue. The applied techniques are invasive sampling methods and may have limitations in studies involving infants or young children. In 1985 the group of McMurchie suggested buccal cheek cells as a marker for dietary fatty acid intake; however fatty acid profiling in cheek cells has not been widely used yet.

In a clinical intervention trial a new method will be tested. The study will consist of two consecutive parts: A) a correlation study will investigate the relationship between established fatty acid markers (red blood cells (RBC), plasma) and the newly proposed markers (cheek cells) before and after intervention B) an intervention study will investigate the time depended implementation and steady state of docosahexaenoic acid DHA in plasma, RBC and cheek cells.

The participants will receive 520 mg DHA daily over a period of 30 days. Blood and cheek cell samples will be collected once prior to study commencement and regularly during intervention.

The proposed study aims at verifying cheek cell analysis results as a non-invasive marker for fatty acid profiling. This will be shown by correlation analyses of fatty acids in cheek cells, erythrocytes and plasma phospholipids. Furthermore, the time kinetics of DHA incorporation into cheek cells will clarify if cheek cell fatty acids can be considered as a short or long term marker.

The new non-invasive method is expected to be extremely valuable as a non-invasive approach for studying the fatty acid profile in human, including infants and young children. Therefore, it is of great interest to validate the new method in a clinical trial.

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
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Apparently healthy males and females
  • Body Mass Index 20-23 kg/m2
  • Average athletic activity

排除标准

  • Fatty fish consumption > 1 per week (salmon, mackerel, sardines, herring)
  • Intake of fish oil 3 months prior to study commencement
  • Weight reduction diet 4 weeks prior to commencement or during intervention
  • Recent (3 months prior to study commencement) medication assumed to interfere with lipid metabolism. The only exception will be the birth control pill, if the same drug (active ingredient) is taken for 3 months prior to study commencement and during the course of the study.
  • Abuse of alcohol or drugs
  • Pregnancy

结局指标

主要结局

Phospholipids in buccal cheek cells

时间窗: assessed basally (before intervention start) and on days 1, 2, 3, 4, 9, 14, 18, 24, 29 after the start of the intervention

the fatty acid composition of buccal cell phospholipids and individual phospholipid species will be assessed and percentages contribution of individual fatty acids or phospholipid species, respectively, will be reported

次要结局

  • Phospholipids in plasma(assessed basally (before intervention start) and on days 1, 2, 3, 4, 9, 14, 18, 24, 29 after start of intervention)
  • Phospholipids in erythrocytes(assessed basally (before intervention start) and on days 1, 2, 3, 4, 9, 14, 18, 24, 29 after start of intervention)

研究者

申办方类型
Other

研究点 (2)

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