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

Primary Purpose

Type 2 Diabetes, Hypercholesterolemia

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

flax lignans

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring type 2 diabetes, lignans, flaxseed, cholesterol

Eligibility Criteria

50 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Outcomes

Primary Outcome Measures

Total cholesterol at 3 months

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00363233

First Posted

August 10, 2006

Last Updated

January 8, 2007

Sponsor

Chinese Academy of Sciences

1. Study Identification

Unique Protocol Identification Number

NCT00363233

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2007

Overall Recruitment Status

Completed

Study Start Date

March 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Chinese Academy of Sciences

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes, Hypercholesterolemia

Keywords

type 2 diabetes, lignans, flaxseed, cholesterol

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

80 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

flax lignans

Primary Outcome Measure Information:

Title

Total cholesterol at 3 months

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xu Lin, MD, PhD

Organizational Affiliation

Institute for Nutritional Sciences, Chinese Academy of Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200031

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

17987126

Citation

Pan A, Sun J, Chen Y, Ye X, Li H, Yu Z, Wang Y, Gu W, Zhang X, Chen X, Demark-Wahnefried W, Liu Y, Lin X. Effects of a flaxseed-derived lignan supplement in type 2 diabetic patients: a randomized, double-blind, cross-over trial. PLoS One. 2007 Nov 7;2(11):e1148. doi: 10.1371/journal.pone.0001148.

Results Reference

derived

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

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