Flaxseed Intervention on Metabolic Syndrome

Chinese Academy of Sciences189 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

189

Conditions

Metabolic Syndrome X

Interventions

flaxseedDIETARY_SUPPLEMENT

30 grams/day of flaxseed for 12 weeks

Health lifestyle counselingBEHAVIORAL

Health lifestyle counseling accroding to AHA reccommendation

Eligibility

Sex: ALLMin age: 35 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Institute for Nutritional Sciences, Chinese Academy of Sciences

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Metabolic syndrome status

Time frame: 12 weeks

Secondary Outcomes

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.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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