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The Potential Effects and Mechanisms of Flax Lignans on Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by:
Chinese Academy of Sciences
ClinicalTrials.gov Identifier:
NCT00363233
First received: August 10, 2006
Last updated: January 8, 2007
Last verified: January 2007

August 10, 2006
January 8, 2007
March 2006
Not Provided
Total cholesterol at 3 months
Same as current
Complete list of historical versions of study NCT00363233 on ClinicalTrials.gov Archive Site
LDL and triglycerides at 3 months; Blood glucose and HbA1C at 3 months
Same as current
Not Provided
Not Provided
 
The Potential Effects and Mechanisms of Flax Lignans on Type 2 Diabetes Mellitus
The Effects of Flax Lignans on Lipid Profile and Glucose Management in Type 2 Diabetes: a Randomized Double-Blind Cross-Over Study

The purpose of the study is to improving the lipid profile and glucose control in type 2 diabetic patients with supplementation of flax lignans. We hypothesize that flax lignans supplement will improve the cholesterol profile and glucose control in type 2 diabetic patients.

The prevalence of type 2 diabetes is increasing dramatically in the last decade in China. Hyperlipidemia is a comorbid condition in type 2 diabetes and increase the adverse health outcomes. Flax lignans, a phytoestrogen found in flaxseed is thought to be the compound responsible for cholesterol-lowering effect of flaxseed. Our purpose is to improving the lipid profile in type 2 diabetic patients with supplementation of flax lignans.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Type 2 Diabetes
  • Hypercholesterolemia
Drug: flax lignans
Not Provided
Pan A, Sun J, Chen Y, Ye X, Li H, Yu Z, Wang Y, Gu W, Zhang X, Chen X, Demark-Wahnefried W, Liu Y, Lin X. Effects of a flaxseed-derived lignan supplement in type 2 diabetic patients: a randomized, double-blind, cross-over trial. PLoS ONE. 2007 Nov 7;2(11):e1148.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
December 2006
Not Provided

Inclusion Criteria:

  • Diagnosed type 2 diabetes
  • Age: 50-79 years old
  • LDL-cholesterol more than 2.9 mmol/l

Exclusion Criteria:

  • Current or previous (within 6 months) use of estrogen therapy
  • Cancer
  • Chronic gastrointestinal diseases
  • Current use of antibiotics
  • Any severe liver or renal diseases
  • Systolic blood pressure more than 180 mmHg or phase 3 hypertension
  • Any severe mental diseases
  • Severe cardio- or cerebro-vascular diseases
Both
50 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00363233
04DZ14007
Not Provided
Not Provided
Chinese Academy of Sciences
Not Provided
Principal Investigator: Xu Lin, MD, PhD Institute for Nutritional Sciences, Chinese Academy of Sciences
Chinese Academy of Sciences
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP