Effects of Legume Intake on Cardiovascular Risk Factors A... | NCT01906099

Studies
Effects of Legume Intake on Cardiovascular Risk Factors Among Adults at Risk for Diabetes

NCT01906099

Sponsor

Isfahan University of Medical Sciences

Status

Completed

Last Update Posted

Jul 23, 2013Estimated

Enrollment

26Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus, Type 2

Interventions

nutritional intervention
life style modification

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Jan 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Jul 9, 2013

First Submission Date that Met QC Criteria

Jul 18, 2013

First Posted Date

Jul 23, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2013

Last Update Posted Date

Jul 23, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Leila Azadbakht, Isfahan University of Medical Sciences, Isfahan University of Medical SciencesPrincipal Investigator

Lead Sponsor

Isfahan University of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This randomized cross-over study was designed to investigate the effects of legume enriched diet consumption on cardiovascular risk factors among first degree relatives of diabetic patients.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
legume enriched diet	Experimental	legume consumption, 4 servings per week, for 6 weeks	Other: nutritional intervention
healthy dietary recommendations	Active Comparator	no nutritional intervention	Other: life style modification

Interventions

Name	Type	Description	Arm Group Labels	Other Names
nutritional intervention	Other		legume enriched diet
life style modification

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fasting blood glucose (mg/dl)	amounts of FBG	14 weeks

Secondary Outcomes

Measure	Description	Time Frame
Hemoglobin A1C (%)	amounts of HbA1C	14 weeks
Total cholesterol (mg/dl)	amounts of TC	14 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

subjects aged more than 30 years
no history of chronic diseases
no use of blood glucose lowering drugs be wiling to participate to study

Exclusion Criteria:

do not follow study protocol
incidence of chronic diseases during the study
to start use of blood glucose lowering drugs or to change dose and type of current medications

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Isfahan University of Medical Sciences		Isfahan			Iran

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided