Clinical trial NCT00204412: Exercise and Flax-Based Nutritional Supplementation for Lowering Cholesterol
Official title: Effectiveness of Flax Lignan and Exercise Training for Improving Lipid Profiles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metabolic Syndrome
Osteoporosis
Keywords: Cholesterol
High density lipoprotein
Low density lipoprotein
Triglyceride
Glucose
Exercise
Fitness
Flax
Lignan
Phytoestrogen
bone
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Canada
First posted: 2005-09-20
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: metabolic syndrome score
timeFrame: 6 months
Secondary outcomes:
measure: Total cholesterol at 2, 4, and 6 months
timeFrame: 6 months
measure: High density lipoprotein at 2, 4, and 6 months
timeFrame: 6 months
measure: Low density lipoprotein at 2, 4, and 6 months
timeFrame: 6 months
measure: Triglycerides at 2, 4, and 6 months
timeFrame: 6 months
measure: Blood glucose at 2, 4, and 6 months
timeFrame: 6 months
measure: Body composition at 6 months
timeFrame: 6 months
measure: Aerobic fitness at 6 months
timeFrame: 6 months
measure: Waist Girth at 6 months
timeFrame: 6 months
measure: Body mass index at 6 months
timeFrame: 6 months
measure: Lumbar spine bone mineral density at 6 months
timeFrame: 6 months
measure: Proximal femur bone mineral density at 6 months
timeFrame: 6 months
measure: Whole body bone mineral density at 6 months
timeFrame: 6 months
measure: Trunk fat skinfolds at 6 months
timeFrame: 6 months
measure: inflammatory cytokines
timeFrame: 6 months
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Philip D Chilibeck, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Saskatchewan
name: H J Biem, MD
role: STUDY_DIRECTOR
affiliation: University of Saskatchewan
name: Lisa Paus-Jenssen, MD
role: STUDY_DIRECTOR
affiliation: University of Saskatchewan
name: Susan Whiting, PhD
role: STUDY_DIRECTOR
affiliation: University of Saskatchewan
name: Punam Pahwa, PhD
role: STUDY_DIRECTOR
References: