Flaxseed Intervention on Metabolic Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

189 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-12-31

Brief Summary

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The purpose of this study is to determine whether daily supplement of 30 grams flaxseed is effective in the treatment of metabolic syndrome (MetS).

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Detailed Description

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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.

Conditions

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Metabolic Syndrome X

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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A

healthy lifestyle counseling + 30 grams/day supplement of Flaxseed

Group Type EXPERIMENTAL

flaxseed

Intervention Type DIETARY_SUPPLEMENT

30 grams/day of flaxseed for 12 weeks

Health lifestyle counseling

Intervention Type BEHAVIORAL

Health lifestyle counseling accroding to AHA reccommendation

B

TLC diet

Group Type SHAM_COMPARATOR

Health lifestyle counseling

Intervention Type BEHAVIORAL

Health lifestyle counseling accroding to AHA reccommendation

Interventions

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flaxseed

30 grams/day of flaxseed for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Health lifestyle counseling

Health lifestyle counseling accroding to AHA reccommendation

Intervention Type BEHAVIORAL

Other Intervention Names

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Health lifestyle counseling accroding to AHA reccommendation

Eligibility Criteria

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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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No