Clinical trial NCT01192269: Cheek Cells - Non-invasive Fatty Acid Status Marker
Official title: Buccal Cheek Cells - a New Non-invasive Fatty Acid Status Marker
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: cheek cells
phospholipids
fatty acids
docosahexaenoic acid
Buccal Cheek cells
non invasive fatty acid status marker
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2010-09-01
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Phospholipids in buccal cheek cells
timeFrame: assessed basally (before intervention start) and on days 1, 2, 3, 4, 9, 14, 18, 24, 29 after the start of the intervention
Secondary outcomes:
measure: Phospholipids in plasma
timeFrame: assessed basally (before intervention start) and on days 1, 2, 3, 4, 9, 14, 18, 24, 29 after start of intervention
measure: Phospholipids in erythrocytes
timeFrame: assessed basally (before intervention start) and on days 1, 2, 3, 4, 9, 14, 18, 24, 29 after start of intervention
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Ludwig Maximilians University
Study officials:
affiliation: Dr. von Hauner Children Hospital, Ludwig-Maximilians-Universitaet Muenchen
name: Berthold V Koletzko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: