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Effects of Legume Consumption on Adiponectin and Inflammatory Markers Among Adults

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
nutritional intervention
life style intervention
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus, Type 2

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Isfahan University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

legume consumption

healthy dietary recommendations

Arm Description

legume consumption, 4 servings per week, for 6 weeks

no nutritional intervention

Outcomes

Primary Outcome Measures

high sensitive C reactive protein (mg/l)
amounts of hs-CRP

Secondary Outcome Measures

Interleukin-6 (pg/ml)
amounts of IL-6
Tumor necrosis factor-α (pg/ml)
amounts of TNF-α
Adiponectin (ng/ml)
amounts of adiponectin

Full Information

First Posted
June 25, 2013
Last Updated
May 16, 2014
Sponsor
Isfahan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01906086
Brief Title
Effects of Legume Consumption on Adiponectin and Inflammatory Markers Among Adults
Official Title
Effects of Legume Consumption on Adiponectin and Inflammatory Markers Among First Degree Relatives of Diabetic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
legume consumption
Arm Type
Experimental
Arm Description
legume consumption, 4 servings per week, for 6 weeks
Arm Title
healthy dietary recommendations
Arm Type
Active Comparator
Arm Description
no nutritional intervention
Intervention Type
Other
Intervention Name(s)
nutritional intervention
Intervention Type
Other
Intervention Name(s)
life style intervention
Primary Outcome Measure Information:
Title
high sensitive C reactive protein (mg/l)
Description
amounts of hs-CRP
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Interleukin-6 (pg/ml)
Description
amounts of IL-6
Time Frame
14 weeks
Title
Tumor necrosis factor-α (pg/ml)
Description
amounts of TNF-α
Time Frame
14 weeks
Title
Adiponectin (ng/ml)
Description
amounts of adiponectin
Time Frame
14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Isfahan University of Medical Sciences
City
Isfahan
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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Effects of Legume Consumption on Adiponectin and Inflammatory Markers Among Adults

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