| January 4, 2008 |
| March 25, 2009 |
| January 2008 |
| December 2009 (final data collection date for primary outcome measure) |
| 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 ] |
| Same as current |
| Complete list of historical versions of study NCT00593632 on ClinicalTrials.gov Archive Site |
| 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 ] |
| Same as current |
| |
| A Randomized Controlled Trial of High Dietary Fiber Intake on Serum Lipids |
| A Randomized Controlled Trial of High Dietary Fiber Intake on Serum Lipids |
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. |
| |
| Phase IV |
| Interventional |
| Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
| Hyperlipidemia |
| Dietary Supplement: Uncle Sam Cereal |
| Active Comparator: Arm is dispensed two 3/4 cup servings of Uncle Sam cereal daily in conjunction with high fiber dietary teaching |
| |
| |
| Recruiting |
| 60 |
| January 2010 |
| December 2009 (final data collection date for primary outcome measure) |
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.
|
| Both |
| 18 Years to 80 Years |
| No |
|
|
| United States |
| |
| NCT00593632 |
| Wael A. Jaber, Cleveland Clinic Foundation |
| 07-852, IRB 07-852 |
| The Cleveland Clinic |
| US Mills, LLC |
| Principal Investigator: |
Wael A Jaber, MD |
The Cleveland Clinic |
|
| Principal Investigator: |
Leslie Cho, MD |
The Cleveland Clinic |
|
|
| The Cleveland Clinic |
| March 2009 |