A Controlled Trial of High Dietary Fiber Intake on Serum Lipids

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2013-07-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Hyperlipidemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High Fiber Intake

Two 3/4 Cup servings of high fiber Uncle Sam cereal daily

Group Type EXPERIMENTAL

Uncle Sam Cereal

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Uncle Sam Cereal

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* All primary and secondary prevention patients aged 18 to 80 years with known or newly diagnosed isolated hypercholesteremia or combined hyperlipidemia.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No