A Controlled Trial of High Dietary Fiber Intake on Serum Lipids

Hyperlipidemia Clinical Trial

Official title:

A Controlled Trial of High Dietary Fiber Intake on Serum Lipids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00593632
• Other study ID #: 07-852
• Status: Completed
• Phase: N/A
• First received: January 4, 2008
• Last updated: March 7, 2017
• Start date: January 2008
• Est. completion date: July 2013

Study information

• Verified date: March 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2013
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias

Intervention

Dietary Supplement:
• Uncle Sam Cereal
two 3/4 cup servings daily of Uncle Sam Cereal dietary instruction on high fiber diet

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	Attune Foods

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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