This trial is active, not recruiting.

Condition hyperlipidemia
Treatment uncle sam cereal
Phase phase 4
Sponsor The Cleveland Clinic
Collaborator US Mills, LLC
Start date January 2008
End date October 2011
Trial size 60 participants
Trial identifier NCT00593632, 07-852, IRB 07-852


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Arm is dispensed two 3/4 cup servings of Uncle Sam cereal daily in conjunction with high fiber dietary teaching
uncle sam cereal
two 3/4 cup servings daily of Uncle Sam Cereal dietary instruction on high fiber diet

Primary Outcomes

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 Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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.

Additional Information

Official title A Randomized Controlled Trial of High Dietary Fiber Intake on Serum Lipids
Principal investigator Wael A Jaber, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2011.
Information provided to ClinicalTrials.gov by The Cleveland Clinic.