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Flaxseed Intervention on Metabolic Syndrome (FIMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00733772
Recruitment Status : Completed
First Posted : August 13, 2008
Last Update Posted : February 5, 2015
Information provided by (Responsible Party):
Xu Lin, Chinese Academy of Sciences

Brief 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).

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Flaxseed Supplement on Cardio-metabolic Risk Factors in Patients With Metabolic Syndrome
Study Start Date : March 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00733772

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China, Shanghai
Institute for Nutritional Sciences, Chinese Academy of Sciences
Shanghai, Shanghai, China, 200031
Sponsors and Collaborators
Chinese Academy of Sciences
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Principal Investigator: Xu Lin, MD, PhD Institute for Nutritional Sciences, Chinese Academy of Sciences
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Xu Lin, Principal Investigator, Chinese Academy of Sciences Identifier: NCT00733772    
Other Study ID Numbers: KSCX1-YW-02
First Posted: August 13, 2008    Key Record Dates
Last Update Posted: February 5, 2015
Last Verified: February 2015
Keywords provided by Xu Lin, Chinese Academy of Sciences:
alpha-Linolenic Acid
LDL Cholesterol
Additional relevant MeSH terms:
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Metabolic Syndrome
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases