NCT00593632

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 15, 2008

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

March 9, 2017

Status Verified

March 1, 2017

Enrollment Period

3.5 years

First QC Date

January 4, 2008

Last Update Submit

March 7, 2017

Conditions

Hyperlipidemia

Keywords

low HDL

Outcome Measures

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

    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.

    12 weeks

Study Arms (1)

High Fiber Intake

EXPERIMENTAL

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

Dietary Supplement: Uncle Sam Cereal

Interventions

Uncle Sam CerealDIETARY_SUPPLEMENT

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

High Fiber Intake

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Wael A Jaber, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

  • Leslie Cho, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 4, 2008

First Posted

January 15, 2008

Study Start

January 1, 2008

Primary Completion

July 1, 2011

Study Completion

July 1, 2013

Last Updated

March 9, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)