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

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00363233
Enrollment
80
Registered
2006-08-15
Start date
2006-03-31
Completion date
2006-12-31
Last updated
2007-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia, Type 2 Diabetes

Keywords

type 2 diabetes, lignans, flaxseed, cholesterol

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.

Interventions

DRUGflax lignans

Sponsors

Chinese Academy of Sciences
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
50 Years to 79 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Total cholesterol at 3 months

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 6, 2026