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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
nutritional intervention
life style modification
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:

  • 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

Sites / Locations

  • Isfahan University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

legume enriched diet

healthy dietary recommendations

Arm Description

legume consumption, 4 servings per week, for 6 weeks

no nutritional intervention

Outcomes

Primary Outcome Measures

Fasting blood glucose (mg/dl)
amounts of FBG

Secondary Outcome Measures

Hemoglobin A1C (%)
amounts of HbA1C
Total cholesterol (mg/dl)
amounts of TC
Low Density Lipoprotein (mg/dl)
amounts of LDL
High Density Lipoprotein (mg/dl)
amounts of HDL
Triglyceride (mg/dl)
amounts of TG

Full Information

First Posted
July 9, 2013
Last Updated
July 18, 2013
Sponsor
Isfahan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01906099
Brief Title
Effects of Legume Intake on Cardiovascular Risk Factors Among Adults at Risk for Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
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
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.

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 enriched diet
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 modification
Primary Outcome Measure Information:
Title
Fasting blood glucose (mg/dl)
Description
amounts of FBG
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Hemoglobin A1C (%)
Description
amounts of HbA1C
Time Frame
14 weeks
Title
Total cholesterol (mg/dl)
Description
amounts of TC
Time Frame
14 weeks
Title
Low Density Lipoprotein (mg/dl)
Description
amounts of LDL
Time Frame
14 weeks
Title
High Density Lipoprotein (mg/dl)
Description
amounts of HDL
Time Frame
14 weeks
Title
Triglyceride (mg/dl)
Description
amounts of TG
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: 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
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 Intake on Cardiovascular Risk Factors Among Adults at Risk for Diabetes

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