Flaxseed Intervention on Metabolic Syndrome (FIMS)
Primary Purpose
Metabolic Syndrome X
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
flaxseed
Health lifestyle counseling
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome X focused on measuring flaxseed, lignans, alpha-Linolenic Acid, LDL Cholesterol
Eligibility Criteria
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.
Sites / Locations
- Institute for Nutritional Sciences, Chinese Academy of Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
A
B
Arm Description
healthy lifestyle counseling + 30 grams/day supplement of Flaxseed
TLC diet
Outcomes
Primary Outcome Measures
Metabolic syndrome status
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.
Full Information
NCT ID
NCT00733772
First Posted
August 11, 2008
Last Updated
February 4, 2015
Sponsor
Chinese Academy of Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00733772
Brief Title
Flaxseed Intervention on Metabolic Syndrome
Acronym
FIMS
Official Title
The Effects of Flaxseed Supplement on Cardio-metabolic Risk Factors in Patients With Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome X
Keywords
flaxseed, lignans, alpha-Linolenic Acid, LDL Cholesterol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
189 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
healthy lifestyle counseling + 30 grams/day supplement of Flaxseed
Arm Title
B
Arm Type
Sham Comparator
Arm Description
TLC diet
Intervention Type
Dietary Supplement
Intervention Name(s)
flaxseed
Intervention Description
30 grams/day of flaxseed for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Health lifestyle counseling
Other Intervention Name(s)
Health lifestyle counseling accroding to AHA reccommendation
Intervention Description
Health lifestyle counseling accroding to AHA reccommendation
Primary Outcome Measure Information:
Title
Metabolic syndrome status
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xu Lin, MD, PhD
Organizational Affiliation
Institute for Nutritional Sciences, Chinese Academy of Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Nutritional Sciences, Chinese Academy of Sciences
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
20826632
Citation
Wu H, Pan A, Yu Z, Qi Q, Lu L, Zhang G, Yu D, Zong G, Zhou Y, Chen X, Tang L, Feng Y, Zhou H, Chen X, Li H, Demark-Wahnefried W, Hu FB, Lin X. Lifestyle counseling and supplementation with flaxseed or walnuts influence the management of metabolic syndrome. J Nutr. 2010 Nov;140(11):1937-42. doi: 10.3945/jn.110.126300. Epub 2010 Sep 8.
Results Reference
derived
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Flaxseed Intervention on Metabolic Syndrome
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