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Exercise and Flax-Based Nutritional Supplementation for Lowering Cholesterol

Effectiveness of Flax Lignan and Exercise Training for Improving Lipid Profiles

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00204412
Enrollment
100
Registered
2005-09-20
Start date
2005-03-31
Completion date
2006-03-31
Last updated
2007-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome, Osteoporosis

Keywords

Cholesterol, High density lipoprotein, Low density lipoprotein, Triglyceride, Glucose, Exercise, Fitness, Flax, Lignan, Phytoestrogen, bone

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.

Interventions

DIETARY_SUPPLEMENTFlax lignan

543 mg SDG per day

walking 45 minutes per day 5 days per week

Sponsors

Heart and Stroke Foundation of Canada
CollaboratorOTHER
University of Saskatchewan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
metabolic syndrome score6 months

Secondary

MeasureTime frame
High density lipoprotein at 2, 4, and 6 months6 months
Low density lipoprotein at 2, 4, and 6 months6 months
Triglycerides at 2, 4, and 6 months6 months
Blood glucose at 2, 4, and 6 months6 months
Body composition at 6 months6 months
Aerobic fitness at 6 months6 months
Total cholesterol at 2, 4, and 6 months6 months
Body mass index at 6 months6 months
Lumbar spine bone mineral density at 6 months6 months
Proximal femur bone mineral density at 6 months6 months
Whole body bone mineral density at 6 months6 months
Trunk fat skinfolds at 6 months6 months
inflammatory cytokines6 months
Waist Girth at 6 months6 months

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026