A Randomized Controlled Trial of High Dietary Fiber Intake on Serum Lipids

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by The Cleveland Clinic.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
US Mills, LLC
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00593632
First received: January 4, 2008
Last updated: June 9, 2011
Last verified: June 2011
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of High Dietary Fiber Intake on Serum Lipids

Resource links provided by NLM:


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 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
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: Wael A. Jaber, Cleveland Clinic Foundation
ClinicalTrials.gov Identifier: NCT00593632     History of Changes
Other Study ID Numbers: 07-852, IRB 07-852
Study First Received: January 4, 2008
Last Updated: June 9, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
low HDL

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 24, 2014