A Randomized Controlled Trial of High Dietary Fiber Intake on Serum Lipids - Full Text View

Sponsor:	The Cleveland Clinic
Collaborator:	US Mills, LLC
Information provided by:	The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT00593632

Purpose

Dietary fiber intake has been shown to have modest effect in lowering cholesterol. However, most of these studies were done with 20g/daily fiber intake. Not much is known about high dietary fiber intake (30-40 g/day) and serum cholesterol. Also, there have been small studies that have shown modest decrease in oxidative stress by increasing dietary fiber intake. The goal of our study is to determine the efficacy /safety of high dietary fiber intake in raising HDL, lowering LDL, and lowering oxidative stress in patients with hyperlipidemia.

Condition	Intervention	Phase
Hyperlipidemia	Dietary Supplement: Uncle Sam Cereal	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	A Randomized Controlled Trial of High Dietary Fiber Intake on Serum Lipids

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Dietary Fiber Diets

Drug Information available for: Lipids

U.S. FDA Resources

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:

To test whether 30-40g of daily dietary fiber increases HDL, lowers total cholesterol and LDL levels in patients at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To test whether Lipoprotein (a), triglyceride level, LDL: HDL ratio, fibrinogen, CRP, Urine f1 2 isoprostane and body weight will be lowered in patients after 12weeks. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Arm is dispensed two 3/4 cup servings of Uncle Sam cereal daily in conjunction with high fiber dietary teaching	Dietary Supplement: Uncle Sam Cereal two 3/4 cup servings daily of Uncle Sam Cereal dietary instruction on high fiber diet

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All primary and secondary prevention patients aged 18 to 80 years with known or newly diagnosed isolated hypercholesteremia or combined hyperlipidemia.
Inclusion criteria include patients with HDL < 35 mg/dL for a man or < 45mg/dL for women irrespective of LDL level.

Exclusion Criteria:

Any patients with unstable angina, untreated hypothyroidism, uncontrolled diabetes, other endocrine or metabolic diseases not actively treated, acute inflammatory diseases, severe gastrointestinal diseases, chronic renal insufficiency (GFR<30), end stage renal disease, liver disease or other severe diseases such as cancer, triglyceride level greater than 600 mg/dL, pregnant females, chronic use of systemic corticosteroid, or anticoagulants.
Patients who were recently started or recently had their lipid lowering medications changed within the last 4 weeks will be excluded.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00593632

Contacts

Contact: Jackie McCluskey, RN

216-444-4803

mcclusj@ccf.org

Locations

United States, Ohio
Cleveland Clinic	Recruiting
Cleveland, Ohio, United States, 44195
Contact: Jackie McCluskey, RN 216-444-4803 mcclusj@ccf.org

Sponsors and Collaborators

The Cleveland Clinic

US Mills, LLC

Investigators

Principal Investigator:	Wael A Jaber, MD	The Cleveland Clinic
Principal Investigator:	Leslie Cho, MD	The Cleveland Clinic

More Information

No publications provided

Responsible Party:	Cleveland Clinic Foundation ( Wael A. Jaber )
Study ID Numbers:	07-852, IRB 07-852
Study First Received:	January 4, 2008
Last Updated:	November 12, 2009
ClinicalTrials.gov Identifier:	NCT00593632 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:

low HDL

Additional relevant MeSH terms:

Metabolic Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on November 27, 2009