A Randomized Controlled Trial of High Dietary Fiber Intake on Serum Lipids
This trial is active, not recruiting.
|Treatment||uncle sam cereal|
|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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Arm is dispensed two 3/4 cup servings of Uncle Sam cereal daily in conjunction with high fiber dietary teaching
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
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
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.
|Official title||A Randomized Controlled Trial of High Dietary Fiber Intake on Serum Lipids|
|Principal investigator||Wael A Jaber, MD|
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