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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00504478
First received: July 19, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  Purpose

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


Condition Intervention
Inflammation
Dietary Supplement: omega-3 fatty acids
Other: high complex carbohydrate diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

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

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

Estimated Enrollment: 150
Study Start Date: January 2008
Estimated Study Completion Date: December 2009
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504478

Contacts
Contact: Shlomo Berliner, MD PhD 972-3-6974961 berliners@tasmc.health.gov.il
Contact: Olga Raz

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Shlomo Berliner, MD PhD The Tel Aviv Sauraski Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00504478     History of Changes
Other Study ID Numbers: TASMC-07-BS-164-CTIL
Study First Received: July 19, 2007
Last Updated: July 19, 2007
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
Inflammation
carbohydrates
omega-3
overweight
diet

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014