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OpenTrials
Completed

NCT Number: NCT00593632

A Controlled Trial of High Dietary Fiber Intake on Serum Lipids

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Uncle Sam Cereal

Dietary Supplement

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

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • Attune Foods

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2013
First posted
Jan 15, 2008
Registry last updated
Mar 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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