NCT00363233

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_2 type-2-diabetes

Timeline
Completed

Started Mar 2006

Shorter than P25 for phase_2 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

January 9, 2007

Status Verified

January 1, 2007

First QC Date

August 10, 2006

Last Update Submit

January 8, 2007

Conditions

Type 2 DiabetesHypercholesterolemia

Keywords

type 2 diabeteslignansflaxseedcholesterol

Outcome Measures

Primary Outcomes (1)

  • Total cholesterol at 3 months

Secondary Outcomes (1)

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

Interventions

flax lignansDRUG

Eligibility Criteria

Age50 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed type 2 diabetes
  • Age: 50-79 years old
  • LDL-cholesterol more than 2.9 mmol/l

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200031, China

Location

Related Publications (1)

  • 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.

    PMID: 17987126DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Hypercholesterolemia

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism Disorders

Study Officials

  • Xu Lin, MD, PhD

    Institute for Nutritional Sciences, Chinese Academy of Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 10, 2006

First Posted

August 15, 2006

Study Start

March 1, 2006

Study Completion

December 1, 2006

Last Updated

January 9, 2007

Record last verified: 2007-01

Locations

CN(1)