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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by The Cleveland Clinic.
Recruitment status was:  Active, not recruiting
US Mills, LLC
Information provided by:
The Cleveland Clinic Identifier:
First received: January 4, 2008
Last updated: June 9, 2011
Last verified: June 2011
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
Dietary Supplement: Uncle Sam Cereal
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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 ]

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 ]

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


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00593632

United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
US Mills, LLC
Principal Investigator: Wael A Jaber, MD The Cleveland Clinic
Principal Investigator: Leslie Cho, MD The Cleveland Clinic
  More Information

Responsible Party: Wael A. Jaber, Cleveland Clinic Foundation 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

Keywords provided by The Cleveland Clinic:
low HDL

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases processed this record on February 23, 2017