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

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

Condition Intervention Phase
Type 2 Diabetes
Drug: flax lignans
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Effects of Flax Lignans on Lipid Profile and Glucose Management in Type 2 Diabetes: a Randomized Double-Blind Cross-Over Study

Resource links provided by NLM:

Further study details as provided by Chinese Academy of Sciences:

Primary Outcome Measures:
  • Total cholesterol at 3 months

Secondary Outcome Measures:
  • LDL and triglycerides at 3 months; Blood glucose and HbA1C at 3 months

Estimated Enrollment: 80
Study Start Date: March 2006
Estimated Study Completion Date: December 2006
Detailed Description:
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.

Ages Eligible for Study:   50 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00363233

China, Shanghai
Institute for Nutritional Sciences, Chinese Academy of Sciences; Huadong Hospital
Shanghai, Shanghai, China, 200031
Sponsors and Collaborators
Chinese Academy of Sciences
Principal Investigator: Xu Lin, MD, PhD Institute for Nutritional Sciences, Chinese Academy of Sciences
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00363233     History of Changes
Other Study ID Numbers: 04DZ14007
Study First Received: August 10, 2006
Last Updated: January 8, 2007

Keywords provided by Chinese Academy of Sciences:
type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders processed this record on May 23, 2017