A Controlled Trial of High Dietary Fiber Intake on Serum Lipids

The Cleveland Clinic50 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hyperlipidemia

Interventions

Uncle Sam CerealDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.