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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Metabolic Syndrome X
Osteoporosis
Bone Diseases
Bone Diseases, Metabolic
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Metabolic Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 23, 2014