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

Phase 2

Completed

• Conditions: Type 2 Diabetes; Hypercholesterolemia

• Registration Number: NCT00363233
• Lead Sponsor: Chinese Academy of Sciences

Brief 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.

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.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-08-10
• Study First Submitted QC: 2006-08-11
• Study First Posted: 2006-08-15
• Study Completion: 2006-12
• Status Verified: 2007-01
• Last Update Submitted: 2007-01-08
• Last Update Posted: 2007-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Total cholesterol at 3 months

Secondary Outcome Measures

Name	Time	Method
LDL and triglycerides at 3 months; Blood glucose and HbA1C at 3 months

Trial Locations

Locations (1)

Institute for Nutritional Sciences, Chinese Academy of Sciences; Huadong Hospital; 🇨🇳 Shanghai, Shanghai, China