A Controlled Trial of High Dietary Fiber Intake on Serum Lipids

The study evaluates high fiber diet intake in patients with hyperlipidemia.

Study Overview

• Status: Completed
• Conditions: Hyperlipidemia
• Intervention / Treatment: Dietary supplement: Uncle Sam Cereal

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Fiber Intake; Two 3/4 Cup servings of high fiber Uncle Sam cereal daily	Dietary supplement: Uncle Sam Cereal; two 3/4 cup servings daily of Uncle Sam Cereal dietary instruction on high fiber diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To test whether 30-40g of daily dietary fiber increases HDL, lowers total cholesterol and LDL levels in patients at 12 weeks	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	12 weeks

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: Attune Foods
• Investigators: Principal Investigator: Wael A Jaber, MD, The Cleveland Clinic; Principal Investigator: Leslie Cho, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2008
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: January 4, 2008
• First Submitted That Met QC Criteria: January 14, 2008
• First Posted (Estimate): January 15, 2008

Study Record Updates

• Last Update Posted (Actual): March 9, 2017
• Last Update Submitted That Met QC Criteria: March 7, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: low HDL
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias
• Other Study ID Numbers: 07-852

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No