The Potential Effects and Mechanisms of Flax Lignans on Type 2 Diabetes Mellitus
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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. |
ClinicalTrials.gov Identifier: NCT00363233 |
Recruitment Status :
Completed
First Posted : August 15, 2006
Last Update Posted : January 9, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes Hypercholesterolemia | Drug: flax lignans | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 80 participants |
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 |
Study Start Date : | March 2006 |
Study Completion Date : | December 2006 |

- Total cholesterol at 3 months
- LDL and triglycerides at 3 months; Blood glucose and HbA1C at 3 months

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Ages Eligible for Study: | 50 Years to 79 Years (Adult, Older Adult) |
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

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
China, Shanghai | |
Institute for Nutritional Sciences, Chinese Academy of Sciences; Huadong Hospital | |
Shanghai, Shanghai, China, 200031 |
Principal Investigator: | Xu Lin, MD, PhD | Institute for Nutritional Sciences, Chinese Academy of Sciences |
ClinicalTrials.gov Identifier: | NCT00363233 |
Other Study ID Numbers: |
04DZ14007 |
First Posted: | August 15, 2006 Key Record Dates |
Last Update Posted: | January 9, 2007 |
Last Verified: | January 2007 |
type 2 diabetes lignans flaxseed cholesterol |
Diabetes Mellitus Diabetes Mellitus, Type 2 Hypercholesterolemia Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders |