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

NCT ID: NCT00363233

Last Updated: 2007-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2006-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Hypercholesterolemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

flax lignans

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chinese Academy of Sciences

OTHER_GOV

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Xu Lin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute for Nutritional Sciences, Chinese Academy of Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Shanghai, Shanghai Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 17987126 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

04DZ14007

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effect of Fiber on Glycemic Index
NCT02615327 COMPLETED NA
Fiber Mix and Glycemic Response
NCT03334643 COMPLETED NA