Back to resultsA Controlled Trial of High Dietary Fiber Intake on Serum Lipids
Primary Purpose
Hyperlipidemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Uncle Sam Cereal
Sponsored by
About this trial
This is an interventional treatment trial for Hyperlipidemia focused on measuring low HDL
Eligibility 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.
Sites / Locations
- Cleveland Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
High Fiber Intake
Arm Description
Two 3/4 Cup servings of high fiber Uncle Sam cereal daily
Outcomes
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
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.
Full Information
NCT ID
NCT00593632
First Posted
January 4, 2008
Last Updated
March 7, 2017
Sponsor
The Cleveland Clinic
Collaborators
Attune Foods
1. Study Identification
Unique Protocol Identification Number
NCT00593632
Brief Title
A Controlled Trial of High Dietary Fiber Intake on Serum Lipids
Official Title
A Controlled Trial of High Dietary Fiber Intake on Serum Lipids
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2008 (Actual)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
Collaborators
Attune Foods
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study evaluates high fiber diet intake in patients with hyperlipidemia.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia
Keywords
low HDL
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Fiber Intake
Arm Type
Experimental
Arm Description
Two 3/4 Cup servings of high fiber Uncle Sam cereal daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Uncle Sam Cereal
Intervention Description
two 3/4 cup servings daily of Uncle Sam Cereal dietary instruction on high fiber diet
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wael A Jaber, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leslie Cho, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Controlled Trial of High Dietary Fiber Intake on Serum Lipids
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