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

July 18, 2013 updated by: Leila Azadbakht, Isfahan University of Medical Sciences
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: healthy dietary recommendations
no nutritional intervention
Other: life style modification
Experimental: legume enriched diet
legume consumption, 4 servings per week, for 6 weeks
Other: nutritional intervention

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1C (%)
Time Frame: 14 weeks
amounts of HbA1C
14 weeks
Total cholesterol (mg/dl)
Time Frame: 14 weeks
amounts of TC
14 weeks
Low Density Lipoprotein (mg/dl)
Time Frame: 14 weeks
amounts of LDL
14 weeks
High Density Lipoprotein (mg/dl)
Time Frame: 14 weeks
amounts of HDL
14 weeks
Triglyceride (mg/dl)
Time Frame: 14 weeks
amounts of TG
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isfahan University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

July 9, 2013

First Submitted That Met QC Criteria

July 18, 2013

First Posted (Estimate)

July 23, 2013

Study Record Updates

Last Update Posted (Estimate)

July 23, 2013

Last Update Submitted That Met QC Criteria

July 18, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • legume intake and CVD risks

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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