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Cheek Cells - Non-invasive Fatty Acid Status Marker

This study has been completed.
Sponsor:
Information provided by:
Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT01192269
First received: August 16, 2010
Last updated: July 2, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Healthy
 Dietary Supplement: DHA (docosahexaenoic acid)

Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Buccal Cheek Cells - a New Non-invasive Fatty Acid Status Marker

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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


Enrollment: 13
Study Start Date: August 2010
Study Completion Date: June 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Docosahexaenoic Acid Supplement

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).

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01192269

Locations
Germany
Ludwig Maximilians University
Munich, Germany, 80337
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
Principal Investigator: Berthold V Koletzko, MD, PhD Dr. von Hauner Children Hospital, Ludwig-Maximilians-Universitaet Muenchen
  More Information

No publications provided

Responsible Party: Prof. Berthold Koletzko, Dr. von Hauner Children Hospital, Ludwig-Maximilians-Universitaet Muenchen
ClinicalTrials.gov Identifier: NCT01192269     History of Changes
Other Study ID Numbers: 116-10
Study First Received: August 16, 2010
Last Updated: July 2, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Ludwig-Maximilians - University of Munich:
cheek cells
phospholipids
fatty acids
 docosahexaenoic acid
Buccal Cheek cells
non invasive fatty acid status marker

Additional relevant MeSH terms:
6-O-palmitoylascorbic acid
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antioxidants
 Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents

ClinicalTrials.gov processed this record on June 18, 2013