Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-24 @ 11:04 PM
NCT ID:
NCT01192269
Brief Summary:
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.
Study:
NCT01192269
Study Brief:
Protocol Section:
NCT01192269