NCT00733772

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2008

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

February 5, 2015

Status Verified

February 1, 2015

Enrollment Period

4 months

First QC Date

August 11, 2008

Last Update Submit

February 4, 2015

Conditions

Metabolic Syndrome X

Keywords

flaxseedlignansalpha-Linolenic AcidLDL Cholesterol

Outcome Measures

Primary Outcomes (1)

  • Metabolic syndrome status

    12 weeks

Secondary Outcomes (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.

    12 weeks

Study Arms (2)

A

EXPERIMENTAL

healthy lifestyle counseling + 30 grams/day supplement of Flaxseed

Dietary Supplement: flaxseedBehavioral: Health lifestyle counseling

B

SHAM COMPARATOR

TLC diet

Behavioral: Health lifestyle counseling

Interventions

flaxseedDIETARY_SUPPLEMENT

30 grams/day of flaxseed for 12 weeks

A
Health lifestyle counselingBEHAVIORAL

Health lifestyle counseling accroding to AHA reccommendation

Also known as: Health lifestyle counseling accroding to AHA reccommendation
AB

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Nutritional Sciences, Chinese Academy of Sciences

Shanghai, Shanghai Municipality, 200031, China

Location

Related Publications (1)

  • 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.

    PMID: 20826632DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Linseed Oil

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fats, UnsaturatedFatsLipidsPlant OilsOilsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Xu Lin, MD, PhD

    Institute for Nutritional Sciences, Chinese Academy of Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 11, 2008

First Posted

August 13, 2008

Study Start

March 1, 2009

Primary Completion

July 1, 2009

Study Completion

December 1, 2009

Last Updated

February 5, 2015

Record last verified: 2015-02

Locations

CN(1)