Inflammation Clinical Trial
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.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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