Cheek Cells - Non-invasive Fatty Acid Status Marker

NCT ID: NCT01192269

Last Updated: 2012-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-06-30

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.

Conditions

Healthy

Keywords

cheek cells; phospholipids; fatty acids; docosahexaenoic acid; Buccal Cheek cells; non invasive fatty acid status marker

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

DHA (docosahexaenoic acid)

Intervention Type: 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).

Interventions

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).

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Dr. von Hauner Children Hospital, Ludwig-Maximilians-Universitaet Muenchen

Principal Investigators

Berthold V Koletzko, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dr. von Hauner Children Hospital, Ludwig-Maximilians-Universitaet Muenchen

Locations

Ludwig Maximilians University

Munich, , Germany

Countries

Germany

Other Identifiers

116-10

Identifier Type: -

Identifier Source: org_study_id