Flaxseed Intervention on Metabolic Syndrome

Study Overview
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Brief Summary
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The purpose of this study is to determine whether daily supplement of 30 grams flaxseed is effective in the treatment of metabolic syndrome (MetS).

Detailed Description
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Metabolic syndrome (MetS), a constellation of metabolic abnormalities including central obesity, dyslipidemia, elevated blood pressure and hyperglycemia, is associated with the development of type 2 diabetes and CVD. It has become one of the major public health challenges in China due to rapidly nutrition transition and the nature of obesity epidemic. Treatment of MetS in China is very important for the prevention of the epidemic of its consequences (such as CVD and type 2 diabetes). Compelling evidence from recent human studies has demonstrated that diet and lifestyle modifications are effective means in MetS management. Flaxseed is a complex food source containing high amounts of alpha-linolenic acid (ALA) - an omega-3 fatty acid - as well as fiber, lignan precursors and other substances that may have an impact on our health. Therefore, the aim of this study is to investigate the effect of flaxseed supplementation on the management of MetS in adult Chinese men and women in a randomized, controlled clinical trial. A total of 200 participants with MetS (defined by NCEP-ATPⅢ criteria) will be randomly assigned to a flaxseed-supplemented diet (30 grams/day) or an isocaloric control diet for 12 weeks. Effects of flaxseed supplementation will be evaluated by measuring metabolic profile (BMI, blood pressure, total cholesterol, triglyceride, LDL-C and HDL-C, fasting glucose and insulin, HbA1C), inflammatory markers (CRP and IL-6), markers of endothelial function (E-selectin, ICAM-1 and VCAM-1), and fatty acid profile.

Official Title
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The Effects of Flaxseed Supplement on Cardio-metabolic Risk Factors in Patients With Metabolic Syndrome

Conditions
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Metabolic Syndrome X

Intervention / Treatment
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* Dietary Supplement: flaxseed
* Behavioral: Health lifestyle counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: with metabolic syndrome Metabolic syndrome was defined based upon the updated National Cholesterol Education Program Adult Treatment Panel III criteria for Asian-Americans as presenting at least 3 of the following components: 1) waist circumference ≥ 90 cm for men or ≥ 80 cm for women; 2) triglycerides ≥1.7mmol/l; 3) HDL cholesterol <1.03 for men or <1.30 for women; 4) blood pressure ≥130/85 mmHg, or current use of antihypertentive medications; 5) fasting glucose ≥5.6mmol/l or previously diagnosed type 2 diabetes or on oral antidiabetic agents or insulin. - Being able to comply with the specified feeding conditions Being able to eat flaxseeds Being between the ages of 35 and 60 years Exclusion Criteria: Pregnancy or lactation Use of insulin Severe kidney disease Cardiovascular diseases, stroke, cancer and psychological disorders Flaxseed allergies or frequently eating flaxseeds or sesame (>90 grams/week) Drug or alcohol abuse.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>healthy lifestyle counseling + 30 grams/day supplement of Flaxseed | Dietary Supplement: flaxseed<br>* 30 grams/day of flaxseed for 12 weeks<br>Behavioral: Health lifestyle counseling<br>* Health lifestyle counseling accroding to AHA reccommendation<br>* Other names: Health lifestyle counseling accroding to AHA reccommendation;|
| Sham Comparator: B<br>TLC diet | Behavioral: Health lifestyle counseling<br>* Health lifestyle counseling accroding to AHA reccommendation<br>* Other names: Health lifestyle counseling accroding to AHA reccommendation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic syndrome status |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cholesterol, triglyceride, HDL-C,LDL-c, fasting glucose and insulin, HbA1C, blood pressure, CRP, IL-6, adiponectin, RBP-4, E-selectin, ICAM-1, VCAM-1, and fatty acid profiles of red blood cells. |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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flaxseed, alpha-Linolenic Acid, LDL Cholesterol, lignans