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CompletedNCT00085800Updated May 15, 2018

Dietary Fiber and Cardiovascular Inflammatory Markers

An observational study in Cardiovascular Diseases, Heart Diseases and Diabetes Mellitus, Non-insulin Dependent, sponsored by Medical University of South Carolina. Completed. Open to participants aged Up to 100 Years. Per ClinicalTrials.gov, last updated 2018-05-15.

Sponsored by Medical University of South Carolina · Observational

Study type
Observational
Ages
Up to 100 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Cardiovascular Diseases
  • Heart Diseases
  • Diabetes Mellitus, Non-insulin Dependent
  • Hypertension
  • Obesity
  • Inflammation
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

Browse Cardiovascular Diseases studies →

Lead sponsor

Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.

Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

No eligibility criteria

05

Study design

06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00085800
Lead sponsor
Medical University of South Carolina
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
First posted
Jun 17, 2004
Start date
May 2004
Primary completion
Mar 2008
Completion
Mar 2008
Last update
May 15, 2018

Study contacts

Dana King
Medical University of South Carolina
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.

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