Effect of HCCD Supplemented With Omega-3 Fatty-Acids on Inflammation in Healthy, Overweight Subjects (HCCD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00504478
Recruitment Status : Unknown
Verified April 2007 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 20, 2007
Last Update Posted : July 20, 2007
Information provided by:
Tel-Aviv Sourasky Medical Center

Brief Summary:
The purpose of this study is to examine the anti inflammatory effect of high complex carbohydrate diet, supplemented by omega-3 fatty acids.

Condition or disease Intervention/treatment Phase
Inflammation Dietary Supplement: omega-3 fatty acids Other: high complex carbohydrate diet Not Applicable

Detailed Description:

Background: Atherosclerosis is the main cause for premature morbidity and mortality in the western world. It becomes evident that one of the main causes for development of atherosclerosis is the presence of low grade, internal inflammation. The inflammatory process leads to endothelial dysfunction, the early event in the pathogenesis of atherosclerosis. The inflammatory process is known to be induced by several factors such as obesity, recurring infections, smoking, and sedentary lifestyle. It was found that weight reduction decreased sub clinical inflammation. It was also found that the composition of the diet affects the inflammatory process.

Working hypothesis and aims: Our preliminary results show that high complex carbohydrate diet (HCCD) has beneficial effect on several markers of inflammation. The aims of this study are to reinforce our preliminary results by measuring the effect of HCCD on additional markers of inflammation (TNFα, IL6) and of endothelial dysfunction (ICAM-1, VCAM-1), and to identify the genes affected by HCCD in monocytes. In addition the aim of this study is to determine whether consumption of omega-3 oil actually increase the anti-inflammatory effect obtained by HCCD.

Methods: 150 healthy overweight volunteers will be divided into 2 groups; HCCD group and HCCD supplemented with the omega-3 fatty acids. Blood sample will be taken following an overnight 12 hour fast, before and after 8 weeks diet, for the following analysis: total cell count, plasma lipids, glucose and insulin, erythrocyte sedimentation rate, fibrinogen, white blood cell count, and CRP. Markers of leukocyte activation will be determined using FACS analysis. In addition, using ELISA, the following pro and anti inflammatory cytokines and markers for endothelial dysfunction will be analyzed: VCAM-1 and ICAM-1. Micro array analysis for genes transcription differences induced by HCCD will be performed in monocytes using Affymetrix chips.

Expected results: We assume that HCCD consumption may improve the inflammatory markers as well as markers of endothelial dysfunction and affect expression of genes involved in inflammation in monocytes. In addition we assume that omega-3 fatty acids will strengthen the positive effect of HCCD on parameters of inflammation.

Importance and probable implications to Medicine: The results of this study may establish scientific basis for guiding people for healthy lifestyle, including the consumption of diet composed of components with anti inflammatory effects, as well as nutritional supplements enhancing anti-inflammatory properties of the diet. This work will also be able to establish the influence of the diet and supplementations on gene expression for inflammatory reaction in monocytes.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : January 2008
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
8-weeks of high complex carbohydrate diet
Other: high complex carbohydrate diet
Experimental: 2
omega-3 fatty acids supplements
Dietary Supplement: omega-3 fatty acids
omega-3 supplement will be given in addition to high complex carbohydrate diet.
Other: high complex carbohydrate diet

Primary Outcome Measures :
  1. markers of inflammation [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. difference in the pattern of monocyte gene expression [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 150 healthy overweight volunteers

Exclusion Criteria:

  • Individuals who had an infective/inflammatory disease during the six month period prior to the commencement of the study, and individuals who are on treatment with statins or any steroidal or non steroidal anti inflammatory agents, except for aspirin at a dose of up to 325 mg/day, will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00504478

Contact: Shlomo Berliner, MD PhD 972-3-6974961
Contact: Olga Raz

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Principal Investigator: Shlomo Berliner, MD PhD The Tel Aviv Sauraski Medical Center Identifier: NCT00504478     History of Changes
Other Study ID Numbers: TASMC-07-BS-164-CTIL
First Posted: July 20, 2007    Key Record Dates
Last Update Posted: July 20, 2007
Last Verified: April 2007

Keywords provided by Tel-Aviv Sourasky Medical Center:

Additional relevant MeSH terms:
Pathologic Processes