Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00504478
Status:
UNKNOWN
Last Update Posted:
2007-07-20
First Post:
2007-07-19
Brief Title:
Effect of HCCD Supplemented With Omega-3 Fatty-Acids on Inflammation in Healthy Overweight Subjects
Sponsor:
Tel-Aviv Sourasky Medical Center
Organization:
Tel-Aviv Sourasky Medical Center
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HCCD
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None