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

Chinese Academy of Sciences80 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Type 2 Diabetes Hypercholesterolemia

Interventions

flax lignansDRUG

Eligibility

Sex: ALLMin age: 50 YearsMax age: 79 Years

Medical Language ↔ Plain English

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

Locations (1)

Institute for Nutritional Sciences, Chinese Academy of Sciences; Huadong Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Total cholesterol at 3 months

Secondary Outcomes

LDL and triglycerides at 3 months; Blood glucose and HbA1C at 3 months

Data from ClinicalTrials.gov

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