CCRC: Understanding the Effects of Omega-3 Fatty Acids Versus Lignans in Flaxseed on Metabolic and Inflammatory Markers Leading to Diabetes and Cardiovascular Disease

Study Overview
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Brief Summary
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The aim of this study is to compare the effects of flaxseed on atherogenic lipids, plasma inflammatory markers, and insulin sensitivity. We hypothesize that flaxseed omega-3 fatty acids will improve the lipid profile (decrease triglyceride, total and LDL-cholesterol and increase HDL-cholesterol). Flaxseed is the richest dietary source of lignan secoisolariciresinol diglucoside (SDG). Lignans are estrogens found in plant sources that behave similar to endogenous estrogens and have been associated with cardiovascular benefits due to their antioxidant activity. Therefore, we also hypothesize that flax-lignans will cause a significant decrease in LDL oxidation and in inflammatory markers such as C-reactive protein (CRP), interleukin-6 (IL-6), IL-1B, serum fatty acid binding protein 4 (FABP-4), and serum amyloid attached to high density lipoprotein (HDL-SAA).

Official Title
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CCRC: Understanding the Effects of Omega-3 Fatty Acids vs. Lignans in Flaxseed on Metabolic and Inflammatory Markers Leading to Diabetes and Cardiovascular Disease.

Conditions
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Body Weight, Lipids, Blood Glucose, Insulin

Intervention / Treatment
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* Dietary Supplement: Flaxseed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or postmenopausal women in the 40-65 years age range. Body Mass Index in the range of 25-39 Exclusion Criteria: Women are are premenopausal Smoking Diabetes Cancer Gout Untreated thyroid disease Kidney Disease Liver Disease Use of lipid lowering drugs Use of insulin sensitizing drugs Use of ACE inhibitors or other blood pressure lowering medications Use of over the counter or prescription anti-obesity medications Weight loss of 10% or more within the last 12 months

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Soybean oil bar<br>A nutrition bar enriched with soybean oil | Dietary Supplement: Flaxseed<br>* Flaxseed omega-3 fatty acids and lignans<br>|
| Experimental: Flaxseed bar with low lignans<br>A nutrition bar enriched with flaxseed oil | Dietary Supplement: Flaxseed<br>* Flaxseed omega-3 fatty acids and lignans<br>|
| Experimental: Flaxseed bars with high lignans<br>A nutrition bar enriched with flaxseed oil and high lignans | Dietary Supplement: Flaxseed<br>* Flaxseed omega-3 fatty acids and lignans<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved lipid profile |  | six weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Flaxseed, Weight loss, Heart health, Diabetes