An interventional study of omega-3 fatty acids and high complex carbohydrate diet in Inflammation, sponsored by Tel-Aviv Sourasky Medical Center. Status unknown. Per ClinicalTrials.gov, last updated 2007-07-20.
Sponsored by Tel-Aviv Sourasky Medical Center · Not applicable, Interventional, and Prevention
The purpose of this study is to examine the anti inflammatory effect of high complex carbohydrate diet, supplemented by omega-3 fatty acids.
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.
3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.
This study's planned enrollment of 150 is above the median of 50 across 2,437 interventional studies indexed under Inflammation.
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Exclusion Criteria:
8-weeks of high complex carbohydrate diet
Other: high complex carbohydrate diet
omega-3 fatty acids supplements
Dietary Supplement: omega-3 fatty acids · Other: high complex carbohydrate diet
omega-3 supplement will be given in addition to high complex carbohydrate diet.
markers of inflammation
Time frame: 2 years
difference in the pattern of monocyte gene expression
Time frame: 1 year
No study locations are listed for this record.
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Tel-Aviv Sourasky Medical Center