Flaxseed Intervention on Metabolic Syndrome (FIMS)
Recruitment status was Recruiting
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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 |
- Plasma Low-density-lipoprotein(LDL) cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- 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 |
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| Contact: An Pan, MSc | +86-21-54920910 | apan@sibs.ac.cn |
| Contact: Hongyu Wu, MSc | +86-21-54920910 | hywu@sibs.ac.cn |
| 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 | |
| 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 May 21, 2013