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

Chinese Academy of Sciences

Status and phase: Completed; Phase 3; Phase 2

Conditions: Hypercholesterolemia; Type 2 Diabetes

Treatments: Drug: flax lignans

Study type: Interventional

Funder types: Other

Identifiers

NCT00363233

04DZ14007

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 50 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind