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Dietary Fiber and Cardiovascular Inflammatory Markers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00085800
First Posted: June 17, 2004
Last Update Posted: April 23, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
To investigate the relationship between dietary fiber and cardiovascular inflammatory markers.

Condition
Cardiovascular Diseases Heart Diseases Diabetes Mellitus, Non-Insulin Dependent Hypertension Obesity Inflammation

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: May 2004
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Detailed Description:

BACKGROUND:

Recent studies have found that diets with higher fiber intake are associated with a reduction in cardiovascular disease (CVD). However, the association does not prove that dietary fiber is actually responsible for lower CVD risk nor does it illuminate potential mechanisms of lower risk if present. Since the diet-CVD connection is strong, and given that CVD is a major contributor to morbidity and mortality, additional information would be valuable. Our preliminary studies and the work of others suggest that there is a significant association between C-reactive protein (CRP) and dietary fiber intake. These observations led us to the following unifying hypothesis: Diets high in fiber are associated with lower levels of inflammatory markers. Our long-term goal is to determine whether inflammation is a key mediator in the link between fiber intake and cardiovascular disease risk.

DESIGN NARRATIVE:

The three specific aims of the project are 1: To determine whether total dietary fiber and or fiber supplementation is associated with levels of inflammatory markers (CRP, fibrinogen, WBC) among adult participants with obesity, hypertension, or diabetes in the National Health and Nutrition Examination Survey 1999-2000; 2: To determine whether 3 weeks on a diet naturally high in fiber (30g/day), or on a diet high in fiber through supplementation, will significantly reduce inflammatory markers compared to a diet low in fiber, in a clinical trial among 30 lean and 30 obese adult hypertensive volunteers; and 3: To determine whether 3 months on a diet supplemented with moderate fiber (extra 7g/day), or high fiber (15g/day), will significantly reduce inflammatory markers compared to a usual diet low in fiber (average 10-15g/day) in a three-month long clinical trial among 180 obese adult volunteers.

To accomplish these aims, three related studies will be conducted. The first will utilize existing data contained in the National Health and Nutrition Examination Survey, a national database of 5773 non-institutionalized adults. The second study will be an additional procedure and laboratory examination to an existing R01 by one of the investigators, to examine the impact of a diet naturally high in fiber on CRP and other inflammatory markers. The third study will consist of new primary data collection in 180 volunteers to evaluate the effect of different levels of fiber supplementation on CRP, fibrinogen, WBC, and interleukin-6. By using existing data, taking advantage of an ongoing protocol, and adding new information through primary data collection, the investigators hope to dramatically increase their understanding of the association between dietary fiber and cardiovascular inflammatory markers. This information could serve to guide constructive changes in nutritional guidelines for reducing CVD risk for millions of at-risk individuals.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00085800


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Dana King Medical University of South Carolina
  More Information

ClinicalTrials.gov Identifier: NCT00085800     History of Changes
Obsolete Identifiers: NCT00294138
Other Study ID Numbers: 1255
First Submitted: June 14, 2004
First Posted: June 17, 2004
Last Update Posted: April 23, 2008
Last Verified: April 2008

Additional relevant MeSH terms:
Diabetes Mellitus
Inflammation
Cardiovascular Diseases
Heart Diseases
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes