Exercise and Flax-Based Nutritional Supplementation for Lowering Cholesterol

Metabolic Syndrome Clinical Trial

Official title:

Effectiveness of Flax Lignan and Exercise Training for Improving Lipid Profiles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00204412
• Other study ID #: 686868
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: November 1, 2007
• Start date: March 2005
• Est. completion date: March 2006

Study information

• Verified date: November 2007
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Osteoporosis

Intervention

Dietary Supplement:
• Flax lignan
543 mg SDG per day

Behavioral:
• Exercise (walking)
walking 45 minutes per day 5 days per week

Locations

Country	Name	City	State
Canada	University of Saskatchewan	Saskatoon	Saskatchewan

Sponsors (2)

Lead Sponsor	Collaborator
University of Saskatchewan	Heart and Stroke Foundation of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	metabolic syndrome score		6 months
Secondary	Total cholesterol at 2, 4, and 6 months		6 months
Secondary	High density lipoprotein at 2, 4, and 6 months		6 months
Secondary	Low density lipoprotein at 2, 4, and 6 months		6 months
Secondary	Triglycerides at 2, 4, and 6 months		6 months
Secondary	Blood glucose at 2, 4, and 6 months		6 months
Secondary	Body composition at 6 months		6 months
Secondary	Aerobic fitness at 6 months		6 months
Secondary	Waist Girth at 6 months		6 months
Secondary	Body mass index at 6 months		6 months
Secondary	Lumbar spine bone mineral density at 6 months		6 months
Secondary	Proximal femur bone mineral density at 6 months		6 months
Secondary	Whole body bone mineral density at 6 months		6 months
Secondary	Trunk fat skinfolds at 6 months		6 months
Secondary	inflammatory cytokines		6 months