Exercise and Flax-Based Nutritional Supplementation for Lowering Cholesterol

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of Flax Lignan and Exercise Training for Improving Lipid Profiles

Conditions
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Metabolic Syndrome, Osteoporosis

Intervention / Treatment
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* Dietary Supplement: Flax lignan
* Behavioral: Exercise (walking)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>flax lignan | Dietary Supplement: Flax lignan<br>* 543 mg SDG per day<br>* Other names: Archer Daniels Midland;Behavioral: Exercise (walking)<br>* walking 45 minutes per day 5 days per week<br>|
| Placebo Comparator: 2<br>placebo | Dietary Supplement: Flax lignan<br>* 543 mg SDG per day<br>* Other names: Archer Daniels Midland;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| metabolic syndrome score |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cholesterol at 2, 4, and 6 months |  | 6 months | 
| High density lipoprotein at 2, 4, and 6 months |  | 6 months | 
| Low 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 | 
| Aerobic fitness at 6 months |  | 6 months | 
| Waist Girth at 6 months |  | 6 months | 
| Body mass index at 6 months |  | 6 months | 
| Lumbar spine bone mineral density at 6 months |  | 6 months | 
| Proximal femur bone mineral density at 6 months |  | 6 months | 
| Whole body bone mineral density at 6 months |  | 6 months | 
| Trunk fat skinfolds at 6 months |  | 6 months | 
| inflammatory cytokines |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glucose, Cholesterol, High density lipoprotein, Low density lipoprotein, Triglyceride, Exercise, Fitness, Flax, Lignan, Phytoestrogen, bone