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Exercise and Flax-Based Nutritional Supplementation for Lowering Cholesterol

NCT ID: NCT00204412

Last Updated: 2007-11-05

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

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Metabolic Syndrome Osteoporosis

Keywords

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Cholesterol High density lipoprotein Low density lipoprotein Triglyceride Glucose Exercise Fitness Flax Lignan Phytoestrogen bone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

flax lignan

Group Type EXPERIMENTAL

Flax lignan

Intervention Type DIETARY_SUPPLEMENT

543 mg SDG per day

Exercise (walking)

Intervention Type BEHAVIORAL

walking 45 minutes per day 5 days per week

2

placebo

Group Type PLACEBO_COMPARATOR

Flax lignan

Intervention Type DIETARY_SUPPLEMENT

543 mg SDG per day

Interventions

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Flax lignan

543 mg SDG per day

Intervention Type DIETARY_SUPPLEMENT

Exercise (walking)

walking 45 minutes per day 5 days per week

Intervention Type BEHAVIORAL

Other Intervention Names

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Archer Daniels Midland

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Heart and Stroke Foundation of Canada

OTHER

Sponsor Role collaborator

University of Saskatchewan

OTHER

Sponsor Role lead

Principal Investigators

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Philip D Chilibeck, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

H J Biem, MD

Role: STUDY_DIRECTOR

University of Saskatchewan

Lisa Paus-Jenssen, MD

Role: STUDY_DIRECTOR

University of Saskatchewan

Susan Whiting, PhD

Role: STUDY_DIRECTOR

University of Saskatchewan

Punam Pahwa, PhD

Role: STUDY_DIRECTOR

University of Saskatchewan

Locations

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University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

Other Identifiers

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686868

Identifier Type: -

Identifier Source: org_study_id