Back to resultsEffects 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
About this trial
This is an interventional health services research trial for Diabetes Mellitus, Type 2
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
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
NCT ID
NCT01906086
First Posted
June 25, 2013
Last Updated
May 16, 2014
Sponsor
Isfahan University of Medical Sciences
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
Learn more about this trial
Effects of Legume Consumption on Adiponectin and Inflammatory Markers Among Adults
We'll reach out to this number within 24 hrs