An interventional study of DHA (docosahexaenoic acid) in Healthy, sponsored by Ludwig-Maximilians - University of Munich. Completed at 1 site in Germany. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-07-03.
Sponsored by Ludwig-Maximilians - University of Munich · Not applicable, Interventional, and Basic science
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.
Ludwig-Maximilians - University of Munich is the lead sponsor of 218 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
DHA supplement: Experimental 1 x 950 mg capsules per day orally, each capsule providing \~520 mg of DHA as a triglyceride. The liquid fill contains DHASCO® oil, derived from the microalgae, Schizochytrium sp., high-oleic sunflower oil, natural mixed tocopherols, ascorbyl palmitate, and rosemary extract (flavouring). The gelatin shell contains glycerin, water, and colouring (carmel, carmine, turmeric).
Dietary Supplement: DHA (docosahexaenoic acid)
1 x 950 mg capsules per day orally, each capsule providing \~520 mg of DHA as a triglyceride. The liquid fill contains DHASCO® oil, derived from the microalgae, Schizochytrium sp., high-oleic sunflower oil, natural mixed tocopherols, ascorbyl palmitate, and rosemary extract (flavouring). The gelatin shell contains glycerin, water, and colouring (carmel, carmine, turmeric).
Phospholipids in buccal cheek cells
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
Time frame: assessed basally (before intervention start) and on days 1, 2, 3, 4, 9, 14, 18, 24, 29 after the start of the intervention
Phospholipids in plasma
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
Time frame: assessed basally (before intervention start) and on days 1, 2, 3, 4, 9, 14, 18, 24, 29 after start of intervention
Phospholipids in erythrocytes
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
Time frame: assessed basally (before intervention start) and on days 1, 2, 3, 4, 9, 14, 18, 24, 29 after start of intervention
This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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Ludwig-Maximilians - University of Munich