Exercise and Flax-Based Nutritional Supplementation for Lowering Cholesterol

Phase 3

Completed

• Conditions: Metabolic Syndrome; Osteoporosis
• Interventions: Dietary Supplement: Flax lignan; Behavioral: Exercise (walking)

• Registration Number: NCT00204412
• Lead Sponsor: University of Saskatchewan

Brief 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.

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.

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Study Completion: 2006-03
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-01
• Last Update Posted: 2007-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Exercise (walking)	flax lignan
2	Flax lignan	placebo
1	Flax lignan	flax lignan

Primary Outcome Measures

Name	Time	Method
metabolic syndrome score	6 months

Secondary Outcome Measures

Name	Time	Method
Total cholesterol at 2, 4, and 6 months	6 months
Aerobic fitness at 6 months	6 months
Body mass index at 6 months	6 months
Lumbar spine bone mineral density at 6 months	6 months
Whole body bone mineral density at 6 months	6 months
inflammatory cytokines	6 months
High density lipoprotein at 2, 4, and 6 months	6 months
Triglycerides at 2, 4, and 6 months	6 months
Blood glucose at 2, 4, and 6 months	6 months
Body composition at 6 months	6 months
Proximal femur bone mineral density at 6 months	6 months
Low density lipoprotein at 2, 4, and 6 months	6 months
Waist Girth at 6 months	6 months
Trunk fat skinfolds at 6 months	6 months

Trial Locations

Locations (1)

University of Saskatchewan; 🇨🇦 Saskatoon, Saskatchewan, Canada