Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085800
Status:
COMPLETED
Last Update Posted:
2018-05-15
First Post:
2004-06-14
Brief Title:
Dietary Fiber and Cardiovascular Inflammatory Markers
Sponsor:
Medical University of South Carolina
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 30gday 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 7gday or high fiber 15gday will significantly reduce inflammatory markers compared to a usual diet low in fiber average 10-15gday 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
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 30gday 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 7gday or high fiber 15gday will significantly reduce inflammatory markers compared to a usual diet low in fiber average 10-15gday 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL076271 | NIH | None | httpsreporternihgovquickSearchR01HL076271 |