Skip to main content
OpenTrials
Completed

NCT Number: NCT00204412

Exercise and Flax-Based Nutritional Supplementation for Lowering Cholesterol

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metabolic Syndrome Behavior Bone Diseases Bone Diseases, Metabolic Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Motor Activity Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5B2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flax lignan

Dietary Supplement

543 mg SDG per day

Other names: Archer Daniels Midland

Exercise (walking)

Behavioral

walking 45 minutes per day 5 days per week

Primary outcomes

  1. metabolic syndrome score

    Time frame: 6 months

Secondary outcomes

  1. Total cholesterol at 2, 4, and 6 months

    Time frame: 6 months

  2. High density lipoprotein at 2, 4, and 6 months

    Time frame: 6 months

  3. Low density lipoprotein at 2, 4, and 6 months

    Time frame: 6 months

  4. Triglycerides at 2, 4, and 6 months

    Time frame: 6 months

  5. Blood glucose at 2, 4, and 6 months

    Time frame: 6 months

  6. Body composition at 6 months

    Time frame: 6 months

  7. Aerobic fitness at 6 months

    Time frame: 6 months

  8. Waist Girth at 6 months

    Time frame: 6 months

  9. Body mass index at 6 months

    Time frame: 6 months

  10. Lumbar spine bone mineral density at 6 months

    Time frame: 6 months

  11. Proximal femur bone mineral density at 6 months

    Time frame: 6 months

  12. Whole body bone mineral density at 6 months

    Time frame: 6 months

  13. Trunk fat skinfolds at 6 months

    Time frame: 6 months

  14. inflammatory cytokines

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Collaborators

  • Heart and Stroke Foundation of Canada

Registry information

Official study title

Effectiveness of Flax Lignan and Exercise Training for Improving Lipid Profiles

Important dates

Study start
2005
Study completion
2006
First posted
Sep 20, 2005
Registry last updated
Nov 5, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.