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NCT00363233 Clinical Trial

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

Type 2 Diabetes Clinical Trial

Official title:
The Effects of Flax Lignans on Lipid Profile and Glucose Management in Type 2 Diabetes: a Randomized Double-Blind Cross-Over Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00363233
Other study ID # 04DZ14007
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received August 10, 2006
Last updated January 8, 2007
Start date March 2006
Est. completion date December 2006

Study information
Verified date January 2007
Source Chinese Academy of Sciences
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 79 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• flax lignans

Locations
Country Name City State
China Institute for Nutritional Sciences, Chinese Academy of Sciences; Huadong Hospital Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Chinese Academy of Sciences

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Total cholesterol at 3 months
Secondary LDL and triglycerides at 3 months; Blood glucose and HbA1C at 3 months
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