Effects of Legume Consumption on Adiponectin and Inflamma... | NCT01906086

Studies
Effects of Legume Consumption on Adiponectin and Inflammatory Markers Among Adults

NCT01906086

Sponsor

Isfahan University of Medical Sciences

Status

Completed

Last Update Posted

May 20, 2014Estimated

Enrollment

26Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus, Type 2

Interventions

nutritional intervention
life style intervention

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

May 2014

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

Jun 25, 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

May 16, 2014

Last Update Posted Date

May 20, 2014Estimated

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

The aim of this randomized cross-over study was to determine the effects of legume consumption on adiponectin and inflammatory 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 consumption	Experimental	legume consumption, 4 servings per week, for 6 weeks	Other: nutritional intervention
healthy dietary recommendations	Active Comparator	no nutritional intervention	Other: life style intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
nutritional intervention	Other		legume consumption
life style intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
high sensitive C reactive protein (mg/l)	amounts of hs-CRP	14 weeks

Secondary Outcomes

Measure	Description	Time Frame
Interleukin-6 (pg/ml)	amounts of IL-6	14 weeks
Tumor necrosis factor-α (pg/ml)	amounts of TNF-α	14 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age more than 30 years
no history of chronic diseases
no use of blood glucose lowering drugs

Exclusion Criteria:

do not use recommended amounts of legumes
incidence of chronic diseases during the study
to start use of blood glucose lowering drugs

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