Exercise and Flax-Based Nutritional Supplementation for Lowering Cholesterol

November 1, 2007 updated by: University of Saskatchewan

Effectiveness of Flax Lignan and Exercise Training for Improving Lipid Profiles

The purpose of our study is to use a flaxseed-based nutritional supplement in combination with exercise training (walking) for improving cholesterol levels. We hypothesize that exercise training will improve cholesterol profile and that adding supplementation with a flaxseed nutritional supplement will further improve cholesterol profile.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Flax supplementation and exercise training each have small beneficial effects for improving blood lipid profile and reducing cardiovascular disease risk. Flax lignan, a phytoestrogen found in flaxseed is thought to be the active compound responsible for the cholesterol-lowering effect of flaxseed. Our purpose is to combine an exercise training program (walking) with flax lignan supplementation for improving blood lipid profile.

Comparisons: Walking (6 days per week) plus flax lignan (500 mg per day) compared to walking plus placebo.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 5B2
        • University of Saskatchewan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 50 years or older

Exclusion Criteria:

  • Currently taking medication for cholesterol
  • Smoker
  • Diabetic
  • Gastrointestinal disease
  • Females on hormone replacement therapy
  • Currently taking a flaxseed supplement
  • Currently engaged in vigorous exercise training

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
placebo
Dietary supplement: Flax lignan
543 mg SDG per day
Other Names:
  • Archer Daniels Midland
Experimental: 1
flax lignan
Dietary supplement: Flax lignan
543 mg SDG per day
Other Names:
  • Archer Daniels Midland
Behavioral: Exercise (walking)
walking 45 minutes per day 5 days per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
metabolic syndrome score
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Total cholesterol at 2, 4, and 6 months
Time Frame: 6 months
6 months
High density lipoprotein at 2, 4, and 6 months
Time Frame: 6 months
6 months
Low density lipoprotein at 2, 4, and 6 months
Time Frame: 6 months
6 months
Triglycerides at 2, 4, and 6 months
Time Frame: 6 months
6 months
Blood glucose at 2, 4, and 6 months
Time Frame: 6 months
6 months
Body composition at 6 months
Time Frame: 6 months
6 months
Aerobic fitness at 6 months
Time Frame: 6 months
6 months
Waist Girth at 6 months
Time Frame: 6 months
6 months
Body mass index at 6 months
Time Frame: 6 months
6 months
Lumbar spine bone mineral density at 6 months
Time Frame: 6 months
6 months
Proximal femur bone mineral density at 6 months
Time Frame: 6 months
6 months
Whole body bone mineral density at 6 months
Time Frame: 6 months
6 months
Trunk fat skinfolds at 6 months
Time Frame: 6 months
6 months
inflammatory cytokines
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Saskatchewan

Collaborators

Heart and Stroke Foundation of Canada

Investigators

  • Principal Investigator: Philip D Chilibeck, PhD, University of Saskatchewan
  • Study Director: H J Biem, MD, University of Saskatchewan
  • Study Director: Lisa Paus-Jenssen, MD, University of Saskatchewan
  • Study Director: Susan Whiting, PhD, University of Saskatchewan
  • Study Director: Punam Pahwa, PhD, University of Saskatchewan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

November 4, 2007

Last Update Submitted That Met QC Criteria

November 1, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 686868

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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