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

Inflammation Clinical Trial

— HCCD  

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00504478
• Other study ID #: TASMC-07-BS-164-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: July 19, 2007
• Last updated: July 19, 2007
• Start date: January 2008
• Est. completion date: December 2009

Study information

• Verified date: April 2007
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Shlomo Berliner, MD PhD
• Phone: 972-3-6974961
• Email: berliners[@]tasmc.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Inflammation

Intervention

Dietary Supplement:
• omega-3 fatty acids
omega-3 supplement will be given in addition to high complex carbohydrate diet.

Other:
• high complex carbohydrate diet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	markers of inflammation		2 years
Secondary	difference in the pattern of monocyte gene expression		1 year