NCT00051415

Brief Summary

Flaxseed, a rich source of fiber, may be a significant component of a cholesterol-reducing diet. The purpose of this study is to evaluate the safety and effectiveness of flaxseed in reducing high cholesterol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2003

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, 2003

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2003

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 15, 2003

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
Last Updated

August 18, 2006

Status Verified

July 1, 2006

First QC Date

January 9, 2003

Last Update Submit

August 17, 2006

Conditions

Hypercholesterolemia

Keywords

FlaxseedCholesterol

Interventions

Flaxseed-supplemented dietBEHAVIORAL

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men over 45 and post-menopausal women
  • LDL cholesterol \> 130 mg/dl

You may not qualify if:

  • Established heart, kidney, or liver disease
  • Diabetes
  • Cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Philippe O Szapary, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

January 9, 2003

First Posted

January 15, 2003

Study Start

January 1, 2003

Study Completion

January 1, 2005

Last Updated

August 18, 2006

Record last verified: 2006-07

Locations

US(1)