Exercise and Flax-Based Nutritional Supplementation for Lowering Cholesterol

This study has been completed.
Sponsor:
Collaborator:
Heart and Stroke Foundation of Canada
Information provided by:
University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT00204412
First received: September 12, 2005
Last updated: November 1, 2007
Last verified: November 2007

September 12, 2005
November 1, 2007
March 2005
Not Provided
metabolic syndrome score [ Time Frame: 6 months ]
Total cholesterol to high density lipoprotein ratio at 2, 4, and 6 months
Complete list of historical versions of study NCT00204412 on ClinicalTrials.gov Archive Site
  • Total cholesterol at 2, 4, and 6 months [ Time Frame: 6 months ]
  • High density lipoprotein at 2, 4, and 6 months [ Time Frame: 6 months ]
  • Low density lipoprotein at 2, 4, and 6 months [ Time Frame: 6 months ]
  • Triglycerides at 2, 4, and 6 months [ Time Frame: 6 months ]
  • Blood glucose at 2, 4, and 6 months [ Time Frame: 6 months ]
  • Body composition at 6 months [ Time Frame: 6 months ]
  • Aerobic fitness at 6 months [ Time Frame: 6 months ]
  • Waist Girth at 6 months [ Time Frame: 6 months ]
  • Body mass index at 6 months [ Time Frame: 6 months ]
  • Lumbar spine bone mineral density at 6 months [ Time Frame: 6 months ]
  • Proximal femur bone mineral density at 6 months [ Time Frame: 6 months ]
  • Whole body bone mineral density at 6 months [ Time Frame: 6 months ]
  • Trunk fat skinfolds at 6 months [ Time Frame: 6 months ]
  • inflammatory cytokines [ Time Frame: 6 months ]
  • 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
Not Provided
Not Provided
 
Exercise and Flax-Based Nutritional Supplementation for Lowering Cholesterol
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Metabolic Syndrome
  • Osteoporosis
  • Dietary Supplement: Flax lignan
    543 mg SDG per day
    Other Name: Archer Daniels Midland
  • Behavioral: Exercise (walking)
    walking 45 minutes per day 5 days per week
  • Experimental: 1
    flax lignan
    Interventions:
    • Dietary Supplement: Flax lignan
    • Behavioral: Exercise (walking)
  • Placebo Comparator: 2
    placebo
    Intervention: Dietary Supplement: Flax lignan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
March 2006
Not Provided

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
Both
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00204412
686868
No
Not Provided
University of Saskatchewan
Heart and Stroke Foundation of Canada
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
University of Saskatchewan
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP