Cardiovascular DiseasesNCT00085800
Dietary Fiber and Cardiovascular Inflammatory Markers
An observational study of Cardiovascular Diseases and Heart Diseases, run by Medical University of South Carolina.
Trial summary
To investigate the relationship between dietary fiber and cardiovascular inflammatory markers. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Diabetes Mellitus, Non-insulin Dependent
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- May 2004to Mar 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
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.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Diabetes Mellitus, Non-insulin Dependent, Hypertension, Obesity, Inflammation
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Diabetes Mellitus, Type 2, Hypertension, Obesity, Inflammation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2004 (estimated)
- Study startMay 2004
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Dana King, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00085800
- Sponsor's protocol ID
- 1255
- Other IDs
- R01HL076271
- Status last verified
- Apr 2008
- First submitted
- 14 Jun 2004
- Last updated
- 15 May 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Fiber and Cardiovascular Inflammatory Markers
- ClinicalTrials.gov ID
- NCT00085800
- Acronym / sponsor ID
- 1255
- Conditions
- Cardiovascular Diseases, Heart Diseases, Diabetes Mellitus, Non-insulin Dependent, Hypertension, Obesity, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- May 2004
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 17 Jun 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dana King
Medical University of South Carolina
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by Medical University of South Carolina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2018.