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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Metabolic Syndrome
Osteoporosis
 Dietary Supplement: Flax lignan
Behavioral: Exercise (walking)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness of Flax Lignan and Exercise Training for Improving Lipid Profiles

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • metabolic syndrome score [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 100
Study Start Date: March 2005
Study Completion Date: March 2006
Arms Assigned Interventions
Experimental: 1
flax lignan
 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
Placebo Comparator: 2
placebo
 Dietary Supplement: Flax lignan
543 mg SDG per day
Other Name: Archer Daniels Midland

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00204412

Locations
Canada, Saskatchewan
University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 5B2
Sponsors and Collaborators
University of Saskatchewan
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00204412     History of Changes
Other Study ID Numbers: 686868
Study First Received: September 12, 2005
Last Updated: November 1, 2007
Health Authority: Canada: Health Canada

Keywords provided by University of Saskatchewan:
Cholesterol
High density lipoprotein
Low density lipoprotein
Triglyceride
Glucose
Exercise
 Fitness
Flax
Lignan
Phytoestrogen
bone

Additional relevant MeSH terms:
Osteoporosis
Metabolic Syndrome X
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
 Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 22, 2013