Flaxseed Intervention on Metabolic Syndrome (FIMS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Chinese Academy of Sciences.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chinese Academy of Sciences
ClinicalTrials.gov Identifier:
NCT00733772
First received: August 11, 2008
Last updated: March 27, 2009
Last verified: March 2009
  Purpose

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: TLC diet education
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Chinese Academy of Sciences:

Primary Outcome Measures:
  • Plasma Low-density-lipoprotein(LDL) cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total cholesterol, triglyceride, HDL-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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: March 2009
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
TLC diet + 30 grams/day supplement of Flaxseed
Dietary Supplement: flaxseed
30 grams/day of flaxseed for 12 weeks
Behavioral: TLC diet education
Standard TLC diet education
Sham Comparator: B
TLC diet
Behavioral: TLC diet education
Standard TLC diet education

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 IDF 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.

  Eligibility

Ages Eligible for Study:   35 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The International Diabetes Federation (IDF) criteria for the diagnosis of the MetS will be used. MetS will be defined with central obesity (defined as waist circumference ≥ 80 cm for women or ≥ 90 cm for men) plus any two of the following four factors:

    • Raised triglycerides level: ≥ 150 mg/dL (1.7 mmol/L), or specific treatment for this lipid abnormality;
    • Reduced HDL cholesterol: < 40 mg/dL (1.0 mmol/L) in males and < 50 mg/dL (1.3 mmol/L) in females, or specific treatment for this lipid abnormality;
    • Elevated blood pressure (BP): systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg, or treatment of previously diagnosed hypertension;
    • Increased fasting plasma glucose (FPG): ≥ 100 mg/dL (5.6 mmol/L), or previously diagnosed type 2 diabetes.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00733772

Contacts
Contact: An Pan, MSc +86-21-54920910 apan@sibs.ac.cn
Contact: Hongyu Wu, MSc +86-21-54920910 hywu@sibs.ac.cn

Locations
China, Shanghai
Institute for Nutritional Sciences, Chinese Academy of Sciences Recruiting
Shanghai, Shanghai, China, 200031
Contact: An Pan, MSc    +86-21-54920910    apan@sibs.ac.cn   
Principal Investigator: Xu Lin, MD, PhD         
Sponsors and Collaborators
Chinese Academy of Sciences
Investigators
Principal Investigator: Xu Lin, MD, PhD Institute for Nutritional Sciences, Chinese Academy of Sciences
  More Information

No publications provided by Chinese Academy of Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Xu Lin, Principal Investigator, Institute for Nutritional Sciences, Chinese Academy of Sciences
ClinicalTrials.gov Identifier: NCT00733772     History of Changes
Other Study ID Numbers: KSCX1-YW-02
Study First Received: August 11, 2008
Last Updated: March 27, 2009
Health Authority: China: Ethics Committee

Keywords provided by Chinese Academy of Sciences:
flaxseed
lignans
alpha-Linolenic Acid
LDL Cholesterol

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 26, 2014