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NCT Number: NCT00363233

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

50 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

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

Shanghai, Shanghai Municipality, 200031, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

flax lignans

Drug

Primary outcomes

  1. Total cholesterol at 3 months

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Chinese Academy of Sciences

Other Gov

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2006
First posted
Aug 15, 2006
Registry last updated
Jan 9, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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