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Exercise and Flax-Based Nutritional Supplementation for Lowering Cholesterol

Primary Purpose

Metabolic Syndrome, Osteoporosis

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Flax lignan
Exercise (walking)
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring Cholesterol, High density lipoprotein, Low density lipoprotein, Triglyceride, Glucose, Exercise, Fitness, Flax, Lignan, Phytoestrogen, bone

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Saskatchewan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

flax lignan

placebo

Outcomes

Primary Outcome Measures

metabolic syndrome score

Secondary Outcome Measures

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

Full Information

First Posted
September 12, 2005
Last Updated
November 1, 2007
Sponsor
University of Saskatchewan
Collaborators
Heart and Stroke Foundation of Canada
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1. Study Identification

Unique Protocol Identification Number
NCT00204412
Brief Title
Exercise and Flax-Based Nutritional Supplementation for Lowering Cholesterol
Official Title
Effectiveness of Flax Lignan and Exercise Training for Improving Lipid Profiles
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Saskatchewan
Collaborators
Heart and Stroke Foundation of Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Osteoporosis
Keywords
Cholesterol, High density lipoprotein, Low density lipoprotein, Triglyceride, Glucose, Exercise, Fitness, Flax, Lignan, Phytoestrogen, bone

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
flax lignan
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Flax lignan
Other Intervention Name(s)
Archer Daniels Midland
Intervention Description
543 mg SDG per day
Intervention Type
Behavioral
Intervention Name(s)
Exercise (walking)
Intervention Description
walking 45 minutes per day 5 days per week
Primary Outcome Measure Information:
Title
metabolic syndrome score
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Total cholesterol at 2, 4, and 6 months
Time Frame
6 months
Title
High density lipoprotein at 2, 4, and 6 months
Time Frame
6 months
Title
Low density lipoprotein at 2, 4, and 6 months
Time Frame
6 months
Title
Triglycerides at 2, 4, and 6 months
Time Frame
6 months
Title
Blood glucose at 2, 4, and 6 months
Time Frame
6 months
Title
Body composition at 6 months
Time Frame
6 months
Title
Aerobic fitness at 6 months
Time Frame
6 months
Title
Waist Girth at 6 months
Time Frame
6 months
Title
Body mass index at 6 months
Time Frame
6 months
Title
Lumbar spine bone mineral density at 6 months
Time Frame
6 months
Title
Proximal femur bone mineral density at 6 months
Time Frame
6 months
Title
Whole body bone mineral density at 6 months
Time Frame
6 months
Title
Trunk fat skinfolds at 6 months
Time Frame
6 months
Title
inflammatory cytokines
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip D Chilibeck, PhD
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
H J Biem, MD
Organizational Affiliation
University of Saskatchewan
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lisa Paus-Jenssen, MD
Organizational Affiliation
University of Saskatchewan
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Susan Whiting, PhD
Organizational Affiliation
University of Saskatchewan
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Punam Pahwa, PhD
Organizational Affiliation
University of Saskatchewan
Official's Role
Study Director
Facility Information:
Facility Name
University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 5B2
Country
Canada

12. IPD Sharing Statement

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Exercise and Flax-Based Nutritional Supplementation for Lowering Cholesterol

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