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Dietary Fiber and Cardiovascular Inflammatory Markers

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Diabetes Mellitus, Non-insulin Dependent

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    June 14, 2004
    Last Updated
    May 14, 2018
    Sponsor
    Medical University of South Carolina
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00085800
    Brief Title
    Dietary Fiber and Cardiovascular Inflammatory Markers
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    April 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2004 (undefined)
    Primary Completion Date
    March 2008 (Actual)
    Study Completion Date
    March 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Medical University of South Carolina
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    To investigate the relationship between dietary fiber and cardiovascular inflammatory markers.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Heart Diseases, Diabetes Mellitus, Non-insulin Dependent, Hypertension, Obesity, Inflammation

    7. Study Design

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dana King
    Organizational Affiliation
    Medical University of South Carolina

    12. IPD Sharing Statement

    Learn more about this trial

    Dietary Fiber and Cardiovascular Inflammatory Markers

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