Exercise and Flax-Based Nutritional Supplementation for Lowering Cholesterol - Full Text View

Sponsors and Collaborators:	University of Saskatchewan Heart and Stroke Foundation of Ontario
Information provided by:	University of Saskatchewan
ClinicalTrials.gov Identifier:	NCT00204412

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 III

MedlinePlus related topics: Cholesterol Dietary Supplements Exercise and Physical Fitness Osteoporosis

Drug Information available for: Dextrose Cholest-5-en-3-ol (3beta)- Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effectiveness of Flax Lignan and Exercise Training for Improving Lipid Profiles

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
1: Experimental flax lignan	Dietary Supplement: Flax lignan 543 mg SDG per day Behavioral: Exercise (walking) walking 45 minutes per day 5 days per week
2: Placebo Comparator placebo	Dietary Supplement: Flax lignan 543 mg SDG per day

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

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 Ontario

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

Study ID Numbers:	686868
Study First Received:	September 12, 2005
Last Updated:	November 1, 2007
ClinicalTrials.gov Identifier:	NCT00204412
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

Study placed in the following topic categories:

Musculoskeletal Diseases
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 16, 2009