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Completed

NCT Number: NCT01192269

Cheek Cells - Non-invasive Fatty Acid Status Marker

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.

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Key information

Conditions

Healthy

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ludwig Maximilians University

Munich, 80337, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DHA (docosahexaenoic acid)

Dietary Supplement

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).

Primary outcomes

  1. Phospholipids in buccal cheek cells

    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

    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

Secondary outcomes

  1. Phospholipids in plasma

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

  2. Phospholipids in erythrocytes

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

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Sep 1, 2010
Registry last updated
Jul 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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