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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00363233
First Posted: August 15, 2006
Last Update Posted: January 9, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Chinese Academy of Sciences
  Purpose
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 Hypercholesterolemia Drug: flax lignans Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
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:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

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.
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00363233


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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.

ClinicalTrials.gov Identifier: NCT00363233     History of Changes
Other Study ID Numbers: 04DZ14007
First Submitted: August 10, 2006
First Posted: August 15, 2006
Last Update Posted: January 9, 2007
Last Verified: January 2007

Keywords provided by Chinese Academy of Sciences:
type 2 diabetes
lignans
flaxseed
cholesterol

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypercholesterolemia
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders


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