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Flaxseed Intervention on Metabolic Syndrome (FIMS)

This study has been completed.
Information provided by (Responsible Party):
Xu Lin, Chinese Academy of Sciences Identifier:
First received: August 11, 2008
Last updated: February 4, 2015
Last verified: February 2015
The purpose of this study is to determine whether daily supplement of 30 grams flaxseed is effective in the treatment of metabolic syndrome (MetS).

Condition Intervention Phase
Metabolic Syndrome X
Dietary Supplement: flaxseed
Behavioral: Health lifestyle counseling
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Flaxseed Supplement on Cardio-metabolic Risk Factors in Patients With Metabolic Syndrome

Resource links provided by NLM:

Further study details as provided by Xu Lin, Chinese Academy of Sciences:

Primary Outcome Measures:
  • Metabolic syndrome status [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 189
Study Start Date: March 2009
Study Completion Date: December 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
healthy lifestyle counseling + 30 grams/day supplement of Flaxseed
Dietary Supplement: flaxseed
30 grams/day of flaxseed for 12 weeks
Behavioral: Health lifestyle counseling
Health lifestyle counseling accroding to AHA reccommendation
Other Name: Health lifestyle counseling accroding to AHA reccommendation
Sham Comparator: B
TLC diet
Behavioral: Health lifestyle counseling
Health lifestyle counseling accroding to AHA reccommendation
Other Name: Health lifestyle counseling accroding to AHA reccommendation

Detailed 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.


Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00733772

China, Shanghai
Institute for Nutritional Sciences, Chinese Academy of Sciences
Shanghai, Shanghai, China, 200031
Sponsors and Collaborators
Chinese Academy of Sciences
Principal Investigator: Xu Lin, MD, PhD Institute for Nutritional Sciences, Chinese Academy of Sciences
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Xu Lin, Principal Investigator, Chinese Academy of Sciences Identifier: NCT00733772     History of Changes
Other Study ID Numbers: KSCX1-YW-02
Study First Received: August 11, 2008
Last Updated: February 4, 2015

Keywords provided by Xu Lin, Chinese Academy of Sciences:
alpha-Linolenic Acid
LDL Cholesterol

Additional relevant MeSH terms:
Metabolic Syndrome X
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases processed this record on May 25, 2017