Flaxseed Intervention on Metabolic Syndrome

Metabolic Syndrome X Clinical Trial

— FIMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00733772
• Other study ID #: KSCX1-YW-02
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 11, 2008
• Last updated: February 4, 2015
• Start date: March 2009
• Est. completion date: December 2009

Study information

• Verified date: February 2015
• Source: Chinese Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: December 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome X
• Syndrome

Intervention

Dietary Supplement:
• flaxseed
30 grams/day of flaxseed for 12 weeks

Behavioral:
• Health lifestyle counseling
Health lifestyle counseling accroding to AHA reccommendation

Locations

Country	Name	City	State
China	Institute for Nutritional Sciences, Chinese Academy of Sciences	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic syndrome status		12 weeks	No
Secondary	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	No